FDA has approved Onureg (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission, or CR with incomplete blood count recovery, following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
FDA has approved Kyprolis (carfilzomib) and Darzalex (daratumumab) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.
Blenrep (belantamab mafodotin-blmf) has received FDA approval as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
Guardant360 CDx assay is the first liquid biopsy companion diagnostic test that uses next-generation sequencing technology to receive FDA approval. The assay uses NGS technology to identify patients with specific types of mutations of the epidermal growth factor receptor gene in a deadly form of metastatic non-small cell lung cancer.
The ClonoSEQ assay received expanded FDA clearance to detect and monitor minimal residual disease in blood or bone marrow from patients with chronic lymphocytic leukemia.
Melflufen (INN melphalan flufenamide) was granted priority review from FDA in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD-38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients). The FDA has set a PDUFA-date (Prescription Drug User Fee Act), which is the target date for their review of the New Drug Application, to February 28, 2021.
FDA has issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System MetastasesExternal Link Disclaimer,” which, if finalized, would provide recommendations to sponsors designing clinical trials of drugs and biological products that are intended to support product labeling describing anti-tumor (preventing or inhibiting the formation or growth of tumors) activity in patients with central nervous system metastases from solid tumors originating outside the CNS.
FDA is providing an update on adverse events reported to the Agency related to breast implants, including breast implant-associated anaplastic large cell lymphoma, and systemic signs and symptoms referred to by patients as breast implant illness, which some patients report after receiving breast implants.
Dragonfly Therapeutics Inc. and Bristol Myers Squibb have entered into a definitive agreement under which Bristol Myers Squibb will be granted the global exclusive license to Dragonfly's interleukin-12 investigational immunotherapy program, including its extended half-life cytokine DF6002.
Thermo Fisher Scientific and Hengrui Therapeutics Inc. are developing a companion diagnostic.
