Corporate Members
FDA and NCCN Approvals
May 2025
We’re excited to share that LUMAKRAS® (sotorasib) in combination with Vectibix® (panitumumab) is approved in a new indication. Please see the product website and the full Prescribing Information for LUMAKRAS® and Vectibix® for more information including the BOXED WARNING and Important Safety Information.
April 2025
New Coding Guidance for Amgen Product
IMDELLTRA® (tarlatamab-dlle) received a permanent J-Code J9026, Injection, tarlatamab-dlle, 1 mg. Effective for dates of service on or after January 1, 2025, the Centers for Medicare, and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding Systems (HCPCS) J-Code for IMDELLTRA® J9026, Injection, tarlatamab-dlle, 1 mg
Please see full prescribing information, including BOXED Warnings -
IMDELLTRA® (tarlatamab-dlle) received a permanent J-Code J9026, Injection, tarlatamab-dlle, 1 mg. Effective for dates of service on or after January 1, 2025, the Centers for Medicare, and Medicaid Services (CMS) has assigned the following Healthcare Common Procedure Coding Systems (HCPCS) J-Code for IMDELLTRA® J9026, Injection, tarlatamab-dlle, 1 mg
Please see full prescribing information, including BOXED Warnings -
November 2024
NCCN Guidelines® Now Recommend a New Treatment Option for Extensive-stage SCLC
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).
June 2025
DATROWAY® (datopotamab deruxtecan-dlnk)
DATROWAY® (datopotamab deruxtecan-dlnk) is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung
cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were:
Warnings and precautions include ILD/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. Serious adverse reactions occurred in 26% of patients who received DATROWAY.
Learn more about using DATROWAY for your patients at www.datrowayhcp.com.
cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
The most common (≥20%) adverse reactions, including laboratory abnormalities, were:
- Stomatitis, nausea, alopecia, fatigue, decreased hemoglobin, decreased lymphocytes, constipation, increased calcium, increased AST, decreased white blood cell count, increased lactate dehydrogenase, musculoskeletal pain, decreased appetite, increased ALT, and rash
Warnings and precautions include ILD/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity. Serious adverse reactions occurred in 26% of patients who received DATROWAY.
Learn more about using DATROWAY for your patients at www.datrowayhcp.com.
March 2025
ENHERTU® (fam-trastuzumab deruxtecan-nxki)
ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-), or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. ENHERTU has Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity. Please see Important Safety Information below.
February 2025
CALQUENCE® (acalabrutinib)
The US Food and Drug Administration (FDA) has approved a new indication for CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Approval was based on results from the Phase III, randomized, double-blind, placebo-controlled, multicenter ECHO trial.
February 2025
DATROWAY® (datopotamab deruxtecan-dlnk)
On January 17, 2025, the US Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The approval was based on the results of the pivotal TROPION-Breast01 Phase III trial.
August 2024
IMFINZI® (durvalumab)
The FDA has approved a new indication for IMFINZI® (durvalumab), in combination with platinum containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is
indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer
(NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Approval was based on results from the Phase III, global, doubleblind, placebo-controlled AEGEAN trial.1
indicated for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer
(NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Approval was based on results from the Phase III, global, doubleblind, placebo-controlled AEGEAN trial.1
April 2025
IMFINZI® (durvalumab)
US Food and Drug Administration (FDA) has approved a new indication for IMFINZI, in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). Approval was based on results from the Phase III, global, open label, randomized NIAGARA trial.
June 2025
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb’s Cell Therapy Labels
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).
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
January 2025
Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S.
Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial
Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S.
Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial
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).
KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph)
Merck would like to inform you that the FDA has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Subcutaneous Injection 165 mg/2,000 units per mL for use in adult patients across most solid tumor indications for KEYTRUDA® (pembrolizumab) Injection 100 mg– whether alone or in combination with other therapies.
•One such indication is the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
•One such indication is the adjuvant treatment of adult patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
July 2025
Pfizer Oncology is pleased to share that on July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm). ELREXFIO is approved for 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 of clinical benefit in a confirmatory trial(s).
For more detailed information, please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.
If you have any questions, please contact me at your earliest convenience. If you prefer not to receive emails like this one, please let me know and I will not send them to you in the future.
Pfizer Oncology is pleased to share that on July 11, 2025, the FDA approved a less frequent dosing option for certain responding patients being treated with ELREXFIO® (elranatamab-bcmm). ELREXFIO is approved for 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 of clinical benefit in a confirmatory trial(s).
For more detailed information, please see full Prescribing Information, including BOXED WARNING, and Medication Guide for ELREXFIO.
If you have any questions, please contact me at your earliest convenience. If you prefer not to receive emails like this one, please let me know and I will not send them to you in the future.
The FDA has approved BRAFTOVI® (encorafenib) in a new indication as part of a combination regimen.
July 2025
LYNOZYFIC™ (linvoseltamab-gcpt) is now approved!
LYNOZYFIC is now approved 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) is now approved!
LYNOZYFIC is now approved 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).
