10 FDA actions that may impact your practice
The FDA has approved or granted special designations to several oncology or hematology agents over the past 2 weeks.
Healio and HemOnc Today present this recap of 10 FDA actions that may be relevant to your practice and your patients.
• The FDA approved selinexor (Xpovio, Karyopharm Therapeutics) in combination with bortezomib (Velcade, Millennium/Takeda) and dexamethasone for treatment of adults with multiple myeloma who received at least one prior therapy. Read more.
• Devimistat (CPI-613, Rafael Pharmaceuticals) received track designation for treatment of acute myeloid leukemia. Read more.
• The FDA approved osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy for patients with non-small cell lung cancer who have EGFR exon 19 deletions or exon 21 L858R mutations. Read more.
• Iptacopan (LNP023, Novartis) received breakthrough therapy designation for treatment of paroxysmal nocturnal hemoglobinuria. Read more.
• The FDA approved relugolix (Orgovyx, Myovant Sciences) for the treatment of men with advanced prostate cancer. Read more.
• Rituximab-arrx (Riabni, Amgen) — the third biosimilar to rituximab (Rituxan; Genentech, Biogen) — received FDA approval for multiple indications. The approval applies to use of the agent for treatment of specific groups of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. Read more.
• Pembrolizumab (Keytruda, Merck) plus fluoropyrimidine-based chemotherapy received priority review designation for first-line treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer. Read more.
• The FDA approved margetuximab-cmkb (Margenza, MacroGenics) for use in combination with chemotherapy for the treatment of adults with metastatic HER2-positive breast cancer. Read more.
• Sotorasib (AMG 510, Amgen) received breakthrough therapy designation for the treatment of patients with locally advanced or metastatic NSCLC who have KRAS G12C mutations and received at least one prior systemic therapy. Read more.
• The FDA placed a clinical hold on a phase 1/phase 2 trial designed to evaluate BPX-601 (Bellicum Pharmaceuticals) — a chimeric antigen receptor T-cell therapy — followed by rimiducid for patients with previously treated metastatic pancreatic or prostate cancer. Read more.