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.
FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma, or who have relapsed after two or more prior lines of therapy.
FDA has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test.
TESARO Inc. and Genentech entered into a clinical collaboration to evaluate the combination of the PD-L1 antibody atezolizumab (Tecentriq), the MEK inhibitor cobimetinib (Cotellic) and TESARO's PARP inhibitor Zejula (niraparib) in patients with platinum-sensitive ovarian cancer.
FDA has approved, under priority review, Venclexta (venetoclax tablets) in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, with or without 17p deletion, who have received at least one prior therapy.
FDA approved Fulphila (pegfilgrastim-jmdb) as a biosimilar to Neulasta (pegfilgrastim) to decrease the chance of infection as suggested by febrile neutropenia in patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.
