FDA Approvals, News & Updates
On December 16, 2019, the FDA approved a new indication for enzalutamide (Xtandi; Pfizer, Astellas) for the treatment of patients with metastatic castration-sensitive prostate cancer. Enzalutamide was previously approved for the treatment of patients with nonmetastatic and metastatic castration-resistant prostate cancer. Read More ›
On December 27, 2019, the FDA approved a new indication for olaparib (Lynparza; AstraZeneca), for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated metastatic pancreatic cancer whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. The FDA also approved the BRACAnalysis CDx test (Myriad Genetics) as a companion diagnostic to select patients with pancreatic cancer who are candidates for treatment with olaparib based on the identification of deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 genes. Read More ›
The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer. Read More ›
On November 21, 2019, the FDA approved acalabrutinib (Calquence; AstraZeneca) as initial or subsequent therapy for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This is the second approval under Project Orbis, a collaboration between the FDA, the Australian Therapeutic Goods Administration, and Health Canada. Read More ›
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease. Read More ›
On November 14, 2019, the FDA granted accelerated approval to zanubrutinib (Brukinsa; BeiGene) for the treatment of patients with mantle-cell lymphoma who have received ≥1 previous therapies. Read More ›
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug Designation to the agent for the treatment of soft tissue sarcomas. Read More ›
On December 2, 2019, Merck announced that the FDA has granted priority review for its supplemental biologics license application for the anti–PD-1 agent pembrolizumab (Keytruda). If approved, the drug would be indicated as monotherapy to treat patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non–muscle-invasive bladder cancer who are ineligible for or have decided not to undergo cystectomy. Read More ›
- Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
- Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease. Read More ›