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FDA and NCCN Approvals

November 2024
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NCCN Guidelines® Now Recommend a New Treatment Option for Extensive-stage SCLC
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
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U.S. Food and Drug Administration Approves Opdivo® (nivolumab) as Adjuvant Treatment for Eligible Patients with Completely Resected Stage IIB or Stage IIC Melanoma
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Now Approved
Breyanzi®—a CAR T cell therapy option for patients with R/R CLL or SLL2
January 2025
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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
CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

​DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based quadruplet regimen approved in the U.S. for patients with newly diagnosed multiple myeloma who are transplant-eligible
The FDA has approved BRAFTOVI® (encorafenib) in a new indication as part of a combination regimen. 
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FDA has approved BOSULIF (bosutinib) for a new indication and has also approved a new formulation.   
 
Pennsylvania Society of Oncology and Hematology