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Baize’an (tislelizumab) / BeiGene, BMSBeiGene Announces Acceptance of a Supplemental New Drug Application for Tislelizumab in Combination with Chemotherapy in First-Line Advanced Non-Squamous Non-Small Cell Lung Cancer in China (GlobeNewswire) - Jun 19, 2020 - "BeiGene, Ltd…announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental new drug application (sNDA) of BeiGene’s anti-PD-1 antibody tislelizumab in combination with chemotherapy for first-line treatment of patients with advanced non-squamous non-small cell lung cancer (NSCLC)…The sNDA in non-squamous NSCLC is supported by clinical results from a Phase 3 trial of tislelizumab in combination with pemetrexed and platinum chemotherapy of investigator’s choice – either carboplatin or cisplatin – in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations (NCT03663205)….Full results of the trial will be presented at an upcoming meeting."Byvasda (bevacizumab biosimilar) / Innovent Biologics, CoherusInnovent Announces the NMPA Granted Marketing Approval for BYVASDA (Bevacizumab Biosimilar) in China (PRNewswire) - Jun 19, 2020 - "Innovent Biologics, Inc....announced that BYVASDA® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China."ipatasertib (GDC-0068) / Roche; abiraterone (DST-2970) / DisperSol TechRoche’s IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints (GlobeNewswire) - Jun 19, 2020 - P3, N=1,101; IPATential150 (NCT03072238); Sponsor: Hoffmann-La Roche; "Phase III IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone compared to current standard-of-care (abiraterone and prednisone/prednisolone alone) plus placebo met its co-primary endpoint of radiographic progression free survival (rPFS) in patients with PTEN loss tumours....In addition to prostate cancer, ipatasertib is being studied in certain types of breast cancer including triple-negative breast cancer (TNBC) and hormone-receptor positive (HR+), HER2- negative breast cancer. Results are anticipated later in 2020."Tazverik (tazemetostat) / Epizyme, EisaiRoche receives FDA approval for cobas EZH2 Mutation Test as a companion diagnostic for patients with follicular lymphoma (PRNewswire) - Jun 19, 2020 - "Roche...announced U.S. Food and Drug Administration (FDA) approval of the cobas® EZH2 Mutation Test as a companion diagnostic for TAZVERIK™(tazemetostat), developed by Epizyme, Inc. This molecular test detects abnormalities in the EZH2, or Enhancer of Zeste Homolog 2, gene in patients with follicular lymphoma (FL), a type of non-Hodgkin lymphoma patients who may be eligible for treatment with TAZVERIK, a cancer drug that acts as a selective EZH2 gene inhibitor....The cobas EZH2 Mutation Test is expected to be commercially available in the U.S. later this year."
