FDA has issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous System MetastasesExternal Link Disclaimer,” which, if finalized, would provide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.
Tecentriq (atezolizumab) received FDA approval in combination with cobimetinib and vemurafenib for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.
Tecartus (brexucabtagene autoleucel), a cell-based gene therapy, received FDA approval for treatment of adult patients diagnosed with mantle cell lymphoma who have not responded to or who have relapsed following other kinds of treatment.
Keytruda has received two sBLA acceptances from FDA for the treatment of triple negative breast cancer:
The hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate, received Breakthrough Designation from FDA for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
FDA has cleared an investigational new drug application for CT-0508, an anti-human epidermal growth factor receptor 2-targeted chimeric antigen receptor macrophage.
BDTX-189 has received Fast Track Designation from FDA for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 mutation or an epidermal growth factor receptor or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.
