FDA Approves Biosimilar for Breast, Stomach Cancer Subtypes


The FDA has approved the Herceptin (trastuzumab) biosimilar Ogivri (MYL-1401O; trastuzumab-dkst), which is co-developed by Mylan and Biocon.

Ogivri has approved indications for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma, the same indications as Herceptin. Genentech, the manufacturer of Herceptin, holds an exclusive license for the metastatic gastric cancer indication. The companies cannot market the drug for that purpose until the exclusive license expires.

“The FDA continues to grow the number of biosimilar approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer, that have a high cost burden for patients,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “We’re committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs.”

Mylan and Biocon submitted a biologics license application (BLA) to the FDA for Ogivri in November 2016, and the agency had set an action deadline of September 3, 2017. In July 2017, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 16-0 to recommend approval of Ogivri. However, on August 30, the FDA announced that it had extended its decision deadline on the BLA by 3 months.

The BLA includes phase III results from HERiTAge, a 2-part, multicenter, double-blind, randomized, parallel-group study. Patients with measurable HER2-positive metastatic breast cancer who had not received prior chemotherapy or Herceptin for metastatic disease were randomly assigned to Ogivri (n =230) or Herceptin with docetaxel or paclitaxel (n = 228).

Patients underwent a minimum of 8 cycles in Part 1 of the trial, with Herceptin continuing until progression. Both forms of Herceptin were administered with a loading dose of 8 mg/kg and a maintenance dose of 6 mg/kg every 3 weeks.

In Part 2, patients who had stable disease or better could continue with Ogivri or Herceptin. The primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival, overall survival, time to progression, safety, and tolerability.

Ogivri demonstrated an ORR after 24 weeks of 69.6 percent among women who received the biosimilar in combination with a taxane compared with a 64 percent ORR for patients who took Herceptin plus a taxane. The ratio of ORR for Ogivri to Herceptin was 1.09. The difference in ORR between the 2 arms was 6.0 percent. At the week 48 cutoff, the median duration of response was 9.7 months in both groups.

In the per protocol population, ORR was 70 percent for Ogivri compared with 67 percent for Herceptin. The ratio of ORR was 1.06.

Progression-free survival was nearly identical between the 2 groups. Median overall survival had not been met in either group.

Safety data also were comparable. Serious adverse events (AEs) occurred in 39.3 percent of the patients in the Ogivri arm compared with 37.0 percent in the Herceptin arm, with neutropenia as the most frequently reported serious AEs in both arms (57.5 percent vs 54.1 percent, respectively).

In a briefing document used for the July ODAC meeting, FDA staff concluded that data from MYL-HER-1002 showed that Ogivri demonstrated a similar pharmacokinetic profile with US- and EU-approved Herceptin.

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