Jazz Pharmaceuticals’s ZIIHERA®
On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test. “The approval of Ziihera, which previously received Breakthrough Therapy Designation from the FDA for this indication, is an important advance and offers the first and only dual HER2-targeted bispecific antibody and chemotherapy-free treatment for patients living with BTC,” said Rob Iannone, Executive Vice President, Global Head of Research and Development, and Chief Medical Officer of Jazz Pharmaceuticals. Zanidatamab is also being developed in clinical trials for other indications by Jazz and BeiGene, Ltd., under license agreements from Zymeworks, which first developed the molecule.
Merus’s BIZENGRI®
Merus N.V. announced on December 4 that the FDA has approved BIZENGRI® (zenocutuzumab-zbco) on an accelerated basis for the treatment of NRG1+ Pancreatic Adenocarcinoma and NRG1+ Non–Small Cell Lung Cancer (NSCLC). BIZENGRI® is the first and only approved treatment for adults with pancreatic adenocarcinoma or non–small cell lung cancer (NSCLC) that are advanced, unresectable or metastatic and harbor a neuregulin 1 (NRG1) gene fusion who have disease progression on or after prior systemic therapy. BIZENGRI® 20 mg/mL injection for intravenous use is expected to be available to patients in the coming weeks.
AstraZeneca’s IMFINZI®
On December 5, AstraZeneca announced that it gained another FDA-approved indication for its cancer drug IMFINZI® (durvalumab). IMFINZI® was approved for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval was granted after securing Priority Review and Breakthrough Therapy Designation for this indication in August 2024.
AstraZeneca also recently announced that its supplemental Biologics License Application (sBLA) for IMFINZI® has been accepted and granted Priority Review for the treatment of patients with muscle-invasive bladder cancer (MIBC).