FDA to Reassess Accelerated Immunotherapy Approvals
March 12th 2021Six indications for immune checkpoint inhibitors granted under the FDA’s accelerated approval process that later failed confirmatory clinical trials are being reassessed as the agency continues an industry-wide evaluation of the pathway.
Study Explores Actionable Pathologic Variants in Caribbean Women With Breast or Ovarian Cancer
March 11th 2021One in 7 Caribbean-born individuals with either breast or ovarian cancer had hereditary disease with an actionable pathogenic variant, which provides the opportunity for the utilization of targeted therapeutics and precise prevention strategies.
PARP Inhibitors Are a Mainstay in Metastatic Breast Cancer
March 8th 2021Olaparib and talazoparib didn't show statistically significant improvements in overall survival compared with chemotherapy in certain patients with metastatic breast cancer. However, the results are unlikely to affect the drugs’ utility in practice, given that both agents continue to show favorable tolerability and disease control.
Tipifarnib Gets Breakthrough Therapy Designation for HRAS-Mutated HNSCC
February 25th 2021The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma with variant allele frequency of 20% or higher following progressive disease on platinum-based chemotherapy.
Prioritize Patients With Cancer for COVID-19 Vaccine, Orgs Say
February 19th 2021Leading organizations, cancer centers, and other institutions sent a letter to President Joe Biden and his administration, as well as other leading public health officials at state health departments advocating for priority access to the COVID-19 vaccine for patients and survivors of cancer.
Vicineum Granted Priority Review for High-Risk, BCG-Unresponsive Bladder Cancer
February 18th 2021The FDA has accepted and granted a priority review designation to the biologics license application for Vicineum for use in patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer.