Recent Notable FDA Approvals, December 13, 2017 | Practical Law

Recent Notable FDA Approvals, December 13, 2017 | Practical Law

The FDA recently approved the second biosimilar to treat cancer and an IVD to detect hundreds of genetic mutations in tumors.

Recent Notable FDA Approvals, December 13, 2017

Practical Law Legal Update w-012-1335 (Approx. 3 pages)

Recent Notable FDA Approvals, December 13, 2017

by Practical Law Life Sciences
The FDA recently approved the second biosimilar to treat cancer and an IVD to detect hundreds of genetic mutations in tumors.
Recent notable FDA drug and device approvals and clearances include:
  • Ozempic®. Novo Nordisk A/S's Ozempic (semaglutide) is a once-weekly injection to improve glycemic control in adults with type 2 diabetes.
  • Avastin®. Genentech, Inc.'s Avastin® (bevacizumab) received full approval to treat adults with glioblastoma that has progressed following prior therapy. Avastin was previously granted provisional approval for this indication under the FDA's accelerated approval program.
  • Ogivri™. Mylan GmbH's Ogivri (trastuzumab-dkst) was approved as a biosimilar to Genentech, Inc.'s Herceptin® (trastuzumab). Ogivri treats patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. This is the second FDA-approved biosimilar to treat cancer and the first to treat breast cancer or stomach cancer (see Legal Update, Recent Notable FDA Approvals, September 20, 2017).
  • Sublocade™. Indivior Inc.'s Sublocade (buprenorphine) is the first injectable depot formulation of buprenorphine, a once-monthly medication-assisted treatment for moderate-to-severe opioid use disorder. Prior to use, patients must have been on a stable dose of buprenorphine treatment for a minimum of seven days. The FDA simultaneously released guidelines for approval of depot formulations of buprenorphine (see Legal Update, FDA Announces New Actions to Encourage Medication-Assisted Therapy for Opioid Abuse).The FDA previously granted Sublocade priority review and fast-track designations.
  • FoundationOne® CDx. Foundation Medicine, Inc.'s CDx (F1CDx) is the first next-generation sequencing-based in vitro diagnostic (IVD) test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. The test can be used as a companion diagnostic for 15 FDA-approved treatments. Most companion diagnostics match one test to one drug. The Centers for Medicare & Medicaid Services (CMS) simultaneously proposed nationwide coverage of the F1CDx. This is the second IVD to be approved and covered under the Parallel Review Program. The FDA-CMS Parallel Review Program is a voluntary program where the agencies concurrently review medical devices to help reduce the time between the FDA's approval of a device and Medicare coverage. The FDA previously granted CDx breakthrough-device designation.