Gina Columbus

FDA Panel Unanimously Supports Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

July 15, 2020

The Food and Drug Administration’s Oncologic Drugs Advisory Committee voted in favor of the agency approving belantamab mafodotin to treat patients with relapsed or refractory multiple myeloma who have previously received at least four therapies.

Erleada May Extend Subsequent Progression in Men With Castration-Resistant Prostate Cancer

September 28, 2019

Morever, the next-generation androgen receptor improved overall survival, compared with placebo, in patients with nonmetastatic castration-resistant prostate cancer, according to updated findings of the phase 3 SPARTAN trial.

FDA Approves Xpovio to Treat Relapsed/Refractory Multiple Myeloma

July 03, 2019

The Food and Drug Administration has granted an accelerated approval to Xpovio in combination with dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma who have received more than four prior therapies.

FDA Approves Frontline Darzalex/Rd in Transplant-Ineligible Myeloma

June 28, 2019

The FDA has approved the combination of Darzalex with Revlimid and dexamethasone (DRd) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

FDA Grants Priority Review to Zejula for Late-Stage Ovarian Cancer

June 25, 2019

The FDA has granted a priority review designation to a supplemental biologics license application for Zejula for the treatment of certain patients with advanced ovarian, fallopian tube or primary peritoneal cancer.

FDA Approves First Malignant Pleural Mesothelioma Therapy in Over 15 Years

May 24, 2019

The Food and Drug Administration has approved the NovoTTF-100L System in combination with pemetrexed and platinum-based chemotherapy for the front-line treatment of patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma.

Food and Drug Administration Panel Supports Pexidartinib for Tenosynovial Giant Cell Tumor

May 14, 2019

The FDA’s Oncologic Drugs Advisory Committee voted in favor of the agency approving pexidartinib to treat adult patients with symptomatic tenosynovial giant cell tumor – a rare, benign lesion that can be locally aggressive and often recurring.