FDA Approvals, News & Updates
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 ›
- Teva Will Resume Production of Vincristine in Response to Shortage
- FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
- FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
On September 17, 2019, the FDA approved a new indication for apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication. Read More ›
On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation. Read More ›
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen Biotech), in combination with bortezomib (Velcade), thalidomide (Thalomid), and dexamethasone, for first-line treatment of multiple myeloma in patients eligible for autologous stem-cell transplant (ASCT). In June 2019, the FDA approved the combination of daratumumab plus lenalidomide (Revlimid) and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for ASCT. The FDA granted this application a priority review. Read More ›