FDA Updates

On May 8, 2020, the FDA approved selpercatinib (Retevmo; Loxo Oncology) capsules for the treatment of 3 types of cancer associated with RET gene mutations or fusions, including (1) metastatic non–small-cell lung cancer, (2) metastatic medullary thyroid cancer, and (3) other types of thyroid cancers. Selpercatinib is the first therapy approved for patients with cancer that is linked to RET mutations. Read More ›

On May 1, 2020, the FDA approved a new formulation of daratumumab (Darzalex; Janssen Biotech) and hyaluronidase-fihj (Faspro; Janssen Biotech) for the treatment of adults with newly diagnosed or with relapsed or refractory multiple myeloma. This new formulation allows for the subcutaneous administration of daratumumab as an alternative to its intravenous (IV) administration. The new formulation is approved for the indications previously approved for IV daratumumab. Read More ›

On April 29, 2020, the FDA accelerated the approval of the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula; GlaxoSmithKline) as the first and only drug approved for first-line maintenance therapy of all patients with advanced ovarian cancer—including epithelial ovarian, fallopian tube, or primary peritoneal cancer—who have had a complete or partial response to first-line platinum-based chemotherapy. Read More ›

On April 28, 2020, the FDA accelerated the approval of a new dosing regimen—400 mg every 6 weeks—for pembrolizumab (Keytruda; Merck) for all the 15 indications currently approved by the FDA for adults using this PD-1 inhibitor. The new dosing regimen is a new option in addition to the current dosing regimen of 200 mg every 3 weeks. This is great news for patients, as well as for oncology providers. Read More ›

Mitomycin gel (Jelmyto), an alkylating drug, is the first and only FDA-approved treatment for patients with low-grade upper-tract urothelial cancer (UTUC), a rare cancer that affects the lining of the urinary system, and offers a nonsurgical treatment alternative for patients with this rare disease. Although the majority of urothelial cancers occur in the bladder, UTUC is part of a group of urothelial cancers that arise in the lining of the kidney or the ureter. Read More ›

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

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