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.
Tagrisso (osimertinib) has received Breakthrough Therapy Designation from FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
Piqray (alpelisib) received approval from the European Commission in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
FDA has accepted Karyopharm Therapeutics Inc.'s supplemental New Drug Application seeking approval for Xpovio—its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with multiple myeloma after at least one prior line of therapy.
NCI's Cancer Therapy Evaluation Program and Karyopharm Therapeutics Inc. have entered into a Cooperative Research and Development Agreement.
