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FDA and NCCN Approvals
September 2026
U.S. FDA Approves DECNUPAZ™ (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options.
U.S. FDA Approves DECNUPAZ™ (pivekimab sunirine-pvzy) for Treatment of Adult Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm, an Ultra-Rare and Aggressive Blood Cancer With Limited Treatment Options.
November 2025
IMDELLTRA® (tarlatamab-dlle) is now fully FDA-approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager (BiTE®) therapy approved in this setting, representing an important milestone for patients and providers.
IMDELLTRA® (tarlatamab-dlle) is now fully FDA-approved for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager (BiTE®) therapy approved in this setting, representing an important milestone for patients and providers.
September 2026
Etcamah (Camizestrant)
Etcamah (Camizestrant), in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) was approved on September 4 in the US for the first line treatment of adult patients with HR+, HER2-, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor (AI) and CDK4/6 inhibitor therapy, based on an FDA authorized test. Etcamah is both an estrogen receptor (ER) antagonist and an oral SERD (Selective Estrogen Receptor Degrader): it is a potent, next-generation oral SERD, that blocks and degrades both ESR1wt and ESR1m receptors.
Etcamah (Camizestrant)
Etcamah (Camizestrant), in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) was approved on September 4 in the US for the first line treatment of adult patients with HR+, HER2-, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor (AI) and CDK4/6 inhibitor therapy, based on an FDA authorized test. Etcamah is both an estrogen receptor (ER) antagonist and an oral SERD (Selective Estrogen Receptor Degrader): it is a potent, next-generation oral SERD, that blocks and degrades both ESR1wt and ESR1m receptors.
July 2026
TRUQAP® (capivasertib)
Truqap (in combination with fulvestrant) was approved in late 2024 for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer harboring one or more PIK3CA, AKT1, or PTEN alterations.
New Prostate Cancer Indication
TRUQAP is now FDA approved in combination with abiraterone and prednisone for the treatment of adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMMN/S), as detected by an FDA-authorized test. This approval makes TRUQAP the first and only targeted treatment approved for this patient population and was supported by results from the Phase III CAPItello-281 trial.
TRUQAP® (capivasertib)
Truqap (in combination with fulvestrant) was approved in late 2024 for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer harboring one or more PIK3CA, AKT1, or PTEN alterations.
New Prostate Cancer Indication
TRUQAP is now FDA approved in combination with abiraterone and prednisone for the treatment of adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (mAPMMN/S), as detected by an FDA-authorized test. This approval makes TRUQAP the first and only targeted treatment approved for this patient population and was supported by results from the Phase III CAPItello-281 trial.
June 2026
IMFINZI®
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI, IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). Approval was based on results from the Phase III, global, open label, randomized POTOMAC trial.
IMFINZI®
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI, IMFINZI in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). Approval was based on results from the Phase III, global, open label, randomized POTOMAC trial.
- In the POTOMAC study, the addition of one year of Imfinzi to BCG induction and maintenance therapy significantly reduced the risk of high-risk disease recurrence or death by 32% compared with BCG alone. The regimen also demonstrated a statistically significant improvement in disease-free outcomes.
- This approval marks the first new therapy for BCG-naive, high-risk NMIBC in more than 30 years and establishes Imfinzi plus BCG as the first and only approved systemic immuno-oncology (IO)-based regimen for this patient population.
June 2026
ENHERTU®
ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now FDA-approved for use in adult patients with HER2-positive eBC in both the neoadjuvant and post-neoadjuvant settings:
ENHERTU®
ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now FDA-approved for use in adult patients with HER2-positive eBC in both the neoadjuvant and post-neoadjuvant settings:
- Neoadjuvant eBC treatment: ENHERTU followed by a taxane, trastuzumab, and pertuzumab (THP) is indicated for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer as determined by an FDA-authorized test
- Post-neoadjuvant eBC treatment: ENHERTU is indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment
May 2026
DATROWAY®
On May 22, 2026, the US Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) as a treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.1,2
DATROWAY®
On May 22, 2026, the US Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) as a treatment for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.1,2
March 2026
CALQUENCE®
The US Food and Drug Administration (FDA) has approved a new treatment regimen for CALQUENCE® (acalabrutinib) in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on results from the randomized, multicenter, open-label phase III AMPLIFY trial.
With this approval, clinicians now have an additional treatment option for patients: the first and only BTKi offering the CHOICE of fixed-duration or continuous regiments in patients with previously untreated CLL.
In addition, the NCCN guidelines recommend acalabrutinib as a preferred first-line treatment option for CLL.
CALQUENCE®
The US Food and Drug Administration (FDA) has approved a new treatment regimen for CALQUENCE® (acalabrutinib) in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on results from the randomized, multicenter, open-label phase III AMPLIFY trial.
With this approval, clinicians now have an additional treatment option for patients: the first and only BTKi offering the CHOICE of fixed-duration or continuous regiments in patients with previously untreated CLL.
In addition, the NCCN guidelines recommend acalabrutinib as a preferred first-line treatment option for CLL.
January 2026
ENHERTU®
ENHERTU® (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, is now FDA-approved as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test. ENHERTU has Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity. Please see Important Safety Information.
ENHERTU®
ENHERTU® (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, is now FDA-approved as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test. ENHERTU has Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity. Please see Important Safety Information.
December 2025
INFINZI
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI, in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) regardless of PD-L1 status. Approval was based on results from the Phase III, global, double-blind, randomized MATTERHORN trial.1,2
Please see Important Product Information below. Feel free to reach out with any questions or to schedule an appointment or request a presentation.
IMPORTANT PRODUCT INFORMATION
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic reactions, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for 3 months after the last dose.
The most frequent serious adverse reactions (≥2%) in patients with resectable GC/GEJC receiving IMFINZI in combination with FLOT chemotherapy in the MATTERHORN study were diarrhea (2.5%) in the neoadjuvant phase and pneumonia (2.5%) in the adjuvant phase. In patients with GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone, serious adverse reactions occurred in 14% of patients.
In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
The safety and effectiveness of IMFINZI has not been established in pediatric patients.
Please see the full Prescribing Information for IMFINZI for important dosage modification and management information specific to adverse reactions.
You may report side effects related to AstraZeneca products .
INFINZI
The US Food and Drug Administration (FDA) has approved a new indication for IMFINZI, in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) regardless of PD-L1 status. Approval was based on results from the Phase III, global, double-blind, randomized MATTERHORN trial.1,2
Please see Important Product Information below. Feel free to reach out with any questions or to schedule an appointment or request a presentation.
IMPORTANT PRODUCT INFORMATION
IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic reactions, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for 3 months after the last dose.
The most frequent serious adverse reactions (≥2%) in patients with resectable GC/GEJC receiving IMFINZI in combination with FLOT chemotherapy in the MATTERHORN study were diarrhea (2.5%) in the neoadjuvant phase and pneumonia (2.5%) in the adjuvant phase. In patients with GC/GEJC in the adjuvant phase of the MATTERHORN study receiving IMFINZI alone, serious adverse reactions occurred in 14% of patients.
In patients with resectable GC/GEJC, the most common adverse reactions in the overall study (occurring in ≥20% of patients) were diarrhea, nausea, peripheral neuropathy, fatigue, alopecia, decreased appetite, rash, abdominal pain, vomiting, musculoskeletal pain, pyrexia, and stomatitis.
The safety and effectiveness of IMFINZI has not been established in pediatric patients.
Please see the full Prescribing Information for IMFINZI for important dosage modification and management information specific to adverse reactions.
You may report side effects related to AstraZeneca products .
October 2025
TAGRISSO (osimertinib)
New Data from the FLAURA2 Trial Regarding TAGRISSO (osimertinib) in combination with pemetrexed and platinum-based chemotherapy has been Released. Please see attached fact sheet and safety information.
October 2025
DATROWAY® (datopotamab deruxtecan-dlnk)
Daiichi Sankyo and AstraZeneca are pleased to announce that DATROWAY® (datopotamab deruxtecan-dlnk) injection, for intravenous infusion has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and Average Sales Price (ASP) by the Centers for Medicare & Medicaid Services (CMS).
December 2025
The J-code for Opdivo Qvantig is J9289, which became effective for dates of service on or after July 1, 2025. This unique code is for the new product, nivolumab and hyaluronidase-nvhy, and should be used in all outpatient settings. The previous temporary codes (J9999 and C9399) are no longer valid for this product and should be discontinued.
The J-code for Opdivo Qvantig is J9289, which became effective for dates of service on or after July 1, 2025. This unique code is for the new product, nivolumab and hyaluronidase-nvhy, and should be used in all outpatient settings. The previous temporary codes (J9999 and C9399) are no longer valid for this product and should be discontinued.
March 2026
FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option.
• HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1
• Accelerated approval follows Breakthrough Therapy Designation and prior FDA approval for
previously treated patients in August 2025
FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option.
• HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1
• Accelerated approval follows Breakthrough Therapy Designation and prior FDA approval for
previously treated patients in August 2025
October 2025
DATROWAY® (datopotamab deruxtecan-dlnk)
Daiichi Sankyo and AstraZeneca are pleased to announce that DATROWAY® (datopotamab deruxtecan-dlnk) injection, for intravenous infusion has been assigned a unique Healthcare Common Procedure Coding System (HCPCS) code and Average Sales Price (ASP) by the Centers for Medicare & Medicaid Services (CMS).
September 2026
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease
Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease
September 2026
U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma.
U.S. FDA Approves Ziihera® (zanidatamab-hrii) with and without Tislelizumab plus Chemotherapy in First-Line HER2+ Advanced Gastroesophageal Adenocarcinoma.
October 2025
FDA Approves Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination as First-Line
Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
FDA Approves Zepzelca® (lurbinectedin) and Atezolizumab (Tecentriq®) Combination as First-Line
Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer
August 2025
Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma
Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma
March 2026
Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
Today marks a pivotal moment for Johnson & Johnson with the launch of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), the first novel therapy doublet regimen for J&J—a new approach to treating adults with relapsed or refractory multiple myeloma (RRMM), with the potential to set a new standard of care (SOC) and redefine expectations for patients. This treatment is now available as early as the second line for patients living with this complex disease. This milestone comes during Myeloma Action Month, when we recognize the importance of advancing therapies that can meaningfully change outcomes. Read the press release here.
Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line
Today marks a pivotal moment for Johnson & Johnson with the launch of TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), the first novel therapy doublet regimen for J&J—a new approach to treating adults with relapsed or refractory multiple myeloma (RRMM), with the potential to set a new standard of care (SOC) and redefine expectations for patients. This treatment is now available as early as the second line for patients living with this complex disease. This milestone comes during Myeloma Action Month, when we recognize the importance of advancing therapies that can meaningfully change outcomes. Read the press release here.
January 2026
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)
We are excited to share an important milestone for the lung cancer community. The U.S. Food and Drug Administration (FDA) has approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for adults with advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.1
You can read our company press release here.
This subcutaneous treatment option is approved for all indications of RYBREVANT® (amivantamab-vmjw). Compared to intravenous delivery, RYBREVANT FASPRO™ may offer higher patient convenience and lower burden on healthcare resources by reducing the administration time from several hours to ~5 minutes (this does not include total clinic time).1-4
With RYBREVANT® plus LAZCLUZE®, patients gained a chemotherapy-free first-line option that targets the disease more precisely and delivers meaningful improvements in survival and delays disease spreading.1,5 RYBREVANT FASPRO™ builds on this progress by shortening administration time and creating the potential for a less burdensome and disruptive treatment.2,4
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj)
We are excited to share an important milestone for the lung cancer community. The U.S. Food and Drug Administration (FDA) has approved RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), the first and only subcutaneously administered therapy for adults with advanced or metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.1
You can read our company press release here.
This subcutaneous treatment option is approved for all indications of RYBREVANT® (amivantamab-vmjw). Compared to intravenous delivery, RYBREVANT FASPRO™ may offer higher patient convenience and lower burden on healthcare resources by reducing the administration time from several hours to ~5 minutes (this does not include total clinic time).1-4
With RYBREVANT® plus LAZCLUZE®, patients gained a chemotherapy-free first-line option that targets the disease more precisely and delivers meaningful improvements in survival and delays disease spreading.1,5 RYBREVANT FASPRO™ builds on this progress by shortening administration time and creating the potential for a less burdensome and disruptive treatment.2,4
September 2025
INLEXO® (gemcitabine intravesical system)
U.S. Food and Drug Administration (FDA) approves INLEXZO™ (gemcitabine intravesical system) for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).
INLEXO® (gemcitabine intravesical system)
U.S. Food and Drug Administration (FDA) approves INLEXZO™ (gemcitabine intravesical system) for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).
September 2026
Merck would like to inform you that WELIREG, in combination with KEYTRUDA or KEYTRUDA QLEX, is indicated for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component ( ccRCC ) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Merck would like to inform you that WELIREG, in combination with KEYTRUDA or KEYTRUDA QLEX, is indicated for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component ( ccRCC ) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
April 2026
Treatment of Adult Patients With Platinum-Resistant Ovarian Cancer KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
Treatment of Adult Patients With Platinum-Resistant Ovarian Cancer KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with paclitaxel, with or without bevacizumab, is indicated for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
March 2026
KEYTRUDA® (pembrolizumab) Injection 100 mg is FDA approved for 44 indications across 19 types of cancer, including certain early-stage and advanced cancers.
One indication that the FDA has now approved is KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
PD-L1 = programmed death ligand 1; CPS = combined positive score.
KEYTRUDA® (pembrolizumab) Injection 100 mg is FDA approved for 44 indications across 19 types of cancer, including certain early-stage and advanced cancers.
One indication that the FDA has now approved is KEYTRUDA, in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.
PD-L1 = programmed death ligand 1; CPS = combined positive score.
February 2026
A new indication for the treatment for Adult Patients With Muscle Invasive Bladder Cancer (MIBC) Who Are Ineligible for Cisplatin-Containing Chemotherapy KEYTRUDA® (pembrolizumab) Injection 100 mg, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy.
August 2026
IBRANCE® (palbociclib)
Pfizer Oncology is pleased to announce that the FDA has updated the Prescribing Information for IBRANCE® (palbociclib) on June 24, 2026, to include new data with an expanded indication. The following information is available for PSOH review:
§ IBRANCE Full Prescribing Information including Medication Guide
IBRANCE® (palbociclib)
Pfizer Oncology is pleased to announce that the FDA has updated the Prescribing Information for IBRANCE® (palbociclib) on June 24, 2026, to include new data with an expanded indication. The following information is available for PSOH review:
§ IBRANCE Full Prescribing Information including Medication Guide
April 2026
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600 E Mutation
March 4, 2026
On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.
FDA Grants Traditional Approval to Encorafenib for Metastatic Colorectal Cancer With a BRAF V600 E Mutation
March 4, 2026
On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.
April 2026
LYNOZYFIC™ (linvoseltamab-gcpt) J-code Availability Brochure
INDICATION AND USAGE
LYNOZYFIC is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
LYNOZYFIC™ (linvoseltamab-gcpt) J-code Availability Brochure
INDICATION AND USAGE
LYNOZYFIC is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
