Gynecologic Cancers

FDA Fast Track Designation Granted to Novel ADC for Heavily Pretreated Platinum-Resistant Ovarian Cancer

August 11, 2020

The FDA has granted a fast track designation to a novel antibody-drug conjugate for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to 3 prior lines of systemic therapy, or for patients who previously received 4 lines of systemic therapy regardless of their platinum status.

FDA Approves HPV Test With Extended Genotyping Capabilities

July 24, 2020

The expanded version of the BD Onclarity HPV Assay received approval for a pre-market approval supplement from the FDA, making it the only assay approved right now that individually identifies and reports human papillomavirus genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, as well as the standard 16,18, and 45.

Neoadjuvant Therapy Impresses in I-SPY 2 Trial for Breast Cancer

July 04, 2020

According to investigators on the phase 2 I-SPY 2 study, the addition durvalumab plus olaparib to treatment with neoadjuvant paclitaxel led to better pathologic complete response rates in patients with high-risk, HER2-negative stage II/III breast cancer compared with paclitaxel alone.