FDA Updates

On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020. Read More ›

On January 23, 2020, the FDA granted accelerated approval to tazemetostat (Tazverik; Epizyme), a methyltransferase inhibitor, for the treatment of metastatic or locally advanced epithelioid sarcoma in adults and pediatric patients aged ≥16 years who are not eligible for complete resection. Read More ›

The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases. 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 ›

• Brukinsa Receives Accelerated FDA Approval for Mantle-Cell Lymphoma
• Ziextenzo Third Biosimilar to Neulasta Approved for Febrile Neutropenia
• Tecentriq Approved with Chemotherapy for First-Line Treatment of Metastatic NSCLC without EGFR or ALK Mutations
• FDA Approves Calquence for Adults with CLL or SL
• Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer

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 ›

This section provides a brief overview of new cancer drugs or new indications approved by the FDA between November 14 and November 21, 2019.

• Brukinsa Receives FDA Approval for Patients with Mantle-Cell Lymphoma
• FDA Approves Adakveo to Reduce Vaso-Occlusive Crises in Patients with Sickle-Cell Disease
• Calquence Receives FDA Approval for the Treatment of Patients with CLL or SLL

Read More ›

The FDA has granted priority review to Merck’s supplemental Biologics License Application for the anti-PD–1 agent pembrolizumab as monotherapy for certain patients with high-risk, non-muscle invasive bladder cancer who are ineligible for or have elected not to undergo cystectomy. Read More ›

On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation. Read More ›

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 ›