The U.S. Food and Drug Administration (FDA) has received the supplemental Biologics License Application (sBLA) submitted by Bristol-Myers Squibb Company for filing and revision of the company’s Yervoy. The medicinal product was designed as an adjuvant therapy for patients who suffer from stage 3 melanoma and are particularly at risk of recurrence after a resection surgical procedure.
Regulatory
FDA Accepts sBLA for Adjuvant Ipilimumab in Melanoma
he FDA has accepted a supplemental Biologics License Application (sBLA) for ipilimumab (Yervoy) as an adjuvant treatment of patients with stage III melanoma at high risk of recurrence following complete resection, according to Bristol-Myers Squibb, the company developing the drug. The FDA is scheduled to make a decision on adjuvant ipilimumab by October 28, 2015.
PD-1 Agents Vie for Frontline Spot in Melanoma Immunotherapy
New checkpoint blockade agents that target the PD-1 pathway are moving forward quickly in the melanoma treatment paradigm and likely will become a frontline immunotherapy choice for patients with advanced or metastatic disease, according to Jason J. Luke, MD, FACP, a leading researcher in the field.
Cobimetinib Receives Priority Review for Advanced Melanoma
The FDA has granted a priority review to the MEK inhibitor cobimetinib for use in combination with the BRAF inhibitor vemurafenib (Zelboraf) to treat patients with BRAF V600–positive advanced melanoma. A final approval decision will come from the FDA by August 11, 2015.