FDA Approvals, News & Updates

Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer

December 2019, Vol 10, No 6 - FDA Approvals, News & Updates

On October 23, 2019, the FDA approved a new indication for the PARP inhibitor niraparib (Zejula; ­Tesaro) for the treatment of patients with homologous recombination deficiency repair (HRD)-positive advanced ovarian, fallopian tube, or primary peritoneal cancer, after receiving ≥3 chemotherapy regimens. HRD is defined by a deleterious or suspected deleterious BRCA mutation, or a genomic instability associated with disease progression more than 6 months after the ­tumor’s response to the last platinum-­based chemotherapy. On the same day, the FDA also approved the Myriad myChoice CDx test to select patients for niraparib therapy based on the HRD tumor status. [ Read More ]

FDA Approves Calquence for Adults with CLL or SLL

December 2019, Vol 10, No 6 - FDA Approvals, News & Updates

On November 21, 2019, the FDA accelerated the approval of acalabrutinib (Calquence; AstraZeneca) for adults with chronic lymphocytic leukemia (CLL) or with small lymphocytic lymphoma. This drug was approved 4 months earlier than the FDA PDUFA date. The FDA used its priority review for these 2 indications and granted ­acalabrutinib a breakthrough therapy designation for these indications. [ Read More ]

Tecentriq Approved with Chemotherapy for First-Line Treatment of Metastatic NSCLC without EGFR or ALK Mutations

December 2019, Vol 10, No 6 - FDA Approvals, News & Updates

On December 3, 2019, the FDA approved atezolizumab (Tecentriq; ­Genentech), in combination with pac­litaxel protein-bound (Abraxane) and carboplatin chemotherapy, for the first-line treatment of adults with metastatic nonsquamous non–small-cell lung cancer (NSCLC) that does not harbor EGFR or ALK genomic mutations. [ Read More ]

Regenerative Medicine Advanced Therapy Designation Granted to ADP-A2M4 for Synovial Sarcoma

Yvette Florio Lane

FDA Approvals, News & Updates, In the News, Synovial Sarcoma

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 ]

FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer

Yvette Florio Lane

Bladder Cancer, FDA Approvals, News & Updates, Immunotherapy

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 ]