If the FDA follows the advice of its Oncologic Drugs Advisory Committee (ODAC), both Keytruda and Tecentriq will remain on the U.S. market, for the time being, with accelerated approval as first-line treatments for certain patients with advanced or metastatic urothelial carcinoma. The committee voted 5-3 April 28 to recommend continuing accelerated approval for Merck & Co. Inc.’s Keytruda (pembrolizumab) and 10-1 for maintaining the accelerated approval of the Roche Group’s Tecentriq (atezolizumab) until the final data come in from a confirmatory trial that’s expected to be completed next year.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akari, Amgen, Calliditas, Chiesi, Inmed, Nkarta, Protalix, Provention, Roche, Sorrento, Takeda, Tarus, Tetra, Vertex, Y-Mabs.
The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the metabolic disease.
The FDA’s premarket review mechanisms for class II medical devices may strike some as little more than so much regulatory esoterica, and several courts have ruled that information about the 510(k) process is inadmissible during jury trials due to the possibility of sowing confusion among jurors. An appellate court in New Jersey has ruled that such an exclusion of evidence is prejudicial in a case involving surgical mesh manufactured by two device companies, however, opening a larger debate about the propriety of such exclusions in product liability litigation for medical devices.
PARIS – One month before the Medical Device Regulation (MDR) comes into force in the EU, the European Association of Notified Bodies (Team-NB) has released the results of its latest annual survey. This survey of CE-marked medical devices compiled data from 26 notified bodies who were members of Team-NB at the end of 2020. According to Team-NB’s 2020 survey, a total of 18,784 valid CE certificates had been issued by last year, representing an increase of 35% over 2010.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: GAO denies Roche challenge of Air Force request; NICE updates atrial fibrillation guidelines.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Fractyl Laboratories, Johnson & Johnson Vision.
In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed.
Astrazeneca plc’s saga of its COVID-19 vaccine continued this week with the European Commission (EC) deciding to begin legal action against the Cambridge, U.K.-based company, claiming it has failed to deliver doses in line with its contract.