Novartis announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Kymriah (tisagenlecleucel, formerly CTL019)—a one-time treatment that uses a patient's own T cells to fight cancer.
FDA has accepted for review a supplemental Biologics License Application for Keytruda, Merck's anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer, regardless of PD-L1 expression.
AstraZeneca and Merck announced Japan's Pharmaceuticals and Medical Devices Agency has approved Lynparza (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated, human epidermal growth factor receptor 2-negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic.
FDA has approved Braftovi capsules in combination with Mektovi tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
Kymab Group Ltd. announced a clinical trial agreement with F. Hoffmann-La Roche Ltd.
Rafael Pharmaceuticals Inc. said FDA has granted orphan drug designation to CPI-613, the company's lead Altered Energy Metabolism Directed drug candidate, for the treatment of Burkitt Lymphoma.
Myriad Genetics Inc. said FDA has accepted its supplementary premarket approval application for BRACAnalysis CDx to be used as a companion diagnostic with Pfizer's PARP inhibitor, talazoparib. The New Drug Application for talazoparib has been granted priority review by the FDA and has a Prescription Drug User Fee Act goal date of December 2018.
Bristol-Myers Squibb Co, said the China National Drug Administration has approved Opdivo (nivolumab injection) for the treatment of locally advanced or metastatic non-small cell lung cancer after prior platinum-based chemotherapy in adult patients without EGFR or ALK genomic tumor aberrations.
Natera Inc. announced a research collaboration with the Institut Jules Bordet, a multidisciplinary cancer reference center in Belgium, using the company's Signatera research-use-only circulating tumor DNA assay to evaluate molecular response and minimal residual disease in women with early stage breast cancer.
FDA has approved bevacizumab (Avastin) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection.