Seven drugs and medical devices approved by the FDA in December:
- Interscope's EndoRotor system — The FDA Dec. 23 authorized the marketing of the EndoRotor system to cut out and remove dead tissue for patients with walled-off pancreatic necrosis, a potentially deadly condition that can occur after an episode of severe acute pancreatitis.
- AstraZeneca's Tagrisso (osimertinib) — The FDA Dec. 18 approved Tagrisso as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
- Integrum's prosthetic implant — The FDA Dec. 18 approved a prosthetic implant made by Integrum called the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system in the U.S. for adults with above-the-knee amputations and can't use a conventional socket prosthesis.
- Myovant Sciences' Orgovyx (relugolix) — The FDA Dec. 18 approved Orgovyx, the first oral hormone therapy for the treatment of men with advanced prostate cancer.
- Miach Orthopaedics' ACL implant — The FDA Dec. 16 approved the marketing of an ACL implant from Miach Orthopaedics that is intended to serve as an alternative to ACL reconstruction to treat ACL tears.
- Roche & Blueprint Medicines' Gavreto — The FDA Dec. 2 approved Gavreto, a drug developed by Roche and Blueprint Medicines, to treat patients 12 and older with advanced or metastatic RET-mutant thyroid tumours. The drug was already approved to treat adults with metastatic RET-positive non-small-cell lung cancer.
- UCLA & UCSF's Gallium 68 PSMA-11 — The FDA Dec. 1 approved Gallium 68 PSMA-11, a drug developed by the University of California Los Angeles and the University of California San Francisco, to aid in the treatment of men with prostate cancer.