FDA approved a supplemental New Drug Application to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphiachromosome-positive chronic myelogenous leukemia.
Amgen said FDA has approved the supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Kisqali (ribociclib) received FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
FDA has accepted for filing a supplemental Biologics License Application for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act target action date is May 1, 2018.
FDA has granted Breakthrough Therapy Designation for Avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma.
FDA has granted orphan drug designation to CG'806, a highly potent pan-FLT3/pan-BTK inhibitor, for the treatment of patients with acute myeloid leukemia.
AstraZeneca said the FDA has accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor with clinical activity against central nervous system metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).
Janssen Biotech Inc. said FDA has granted priority review designation for the New Drug Application for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, said that it has entered into a worldwide collaboration and license agreement with Legend Biotech USA Inc. and Legend Biotech Ireland Limited, subsidiaries of Genscript Biotech Corp., to develop, manufacture and commercialize a chimeric antigen receptor T-cell drug candidate, LCAR-B38M, which specifically targets the B-cell maturation antigen. LCAR-B38M is currently accepted for review by the China Food and Drug Administration and in the planning phase of clinical studies in the United States for multiple myeloma.
ABILITY PHARMACEUTICALS of Barcelona, Spain, received orphan-drug designation from FDA for ABTL0812, for the treatment of pancreatic cancer. This regulatory milestone comes after the ODD in the pediatric cancer neuroblastoma granted by EMA and FDA in 2015. In preclinical studies, ABTL0812 have shown efficacy in pancreatic cancer as single agent and synergistic effect (by 8... […]
