FDA has granted priority review for a new supplemental Biologics License Application for Keytruda, which seeks approval of the anti-PD-1 therapy as monotherapy in patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
FDA accepted a new drug application for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements for Priority Review.
The National Medical Products Administration in China approved Merck's anti-PD-1 Keytruda in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer.
China's National Medical Products Administration granted AstraZeneca and Merck marketing authorization for Lynparza (olaparib) as a first-line maintenance treatment of adult patients with newly diagnosed advanced germline or somatic BRCA mutated (gBRCAm or sBRCAm) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. The companies received marketing authorization Dec. 5.
FDA takes second action under international collaboration, approving treatment option for CLL or SLL
As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. This new approved indication for Calquence provides a new treatment option for patients with CLL or SLL as an initial or subsequent therapy.
FDA approved Q BioMed Inc.'s contract manufacturer IsoTherapeutics Group LLC Nov. 20, which it cleared to manufacture the company's FDA-approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
FDA approved Adakveo (crizanlizumab-tmca) to reduce the frequency of vaso-occlusive crises in adults and pediatric patients 16 and older with sickle cell disease.
FDA approved Alnylam Pharmaceuticals Inc.'s Givlaari (givosiran) for adults with acute hepatic porphyria.
The European Commission has approved Merck's Keytruda as monotherapy or in combination with platinum and 5-fluorouracil chemotherapy, for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 (combined positive score [CPS] ≥1). The drug was approved Nov. 20.
The European Commission has has granted marketing authorization for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd) as treatment for adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
