This Week at FDA: FDA seeks new CDRH director, new oncology approvals, ICH M12 adopted

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA began its search for a successor to long-time device chief Jeff Shuren and granted new or expanded indications to several cancer drugs.

Following last week’s surprise announcement that Jeff Shuren, who led the Center for Devices and Radiological Health (CDRH) for the last 15 years, was leaving FDA, the agency officially posted the job announcement for his vacancy. Interested parties can submit their applications for the position through 28 August.

FDA published a blog post about the increasing use of artificial intelligence/machine learning (AI/ML) to identify patient populations who may benefit from certain treatments. As an example, the agency highlighted how a CDER review team used AI/ML to identify patients who were most likely to benefit from Kineret (anakinra) injections, used to treat hospitalized COVID-19 patients with pneumonia requiring supplemental oxygen. It noted this was the first time CDER used AI/ML in its regulatory decision-making, which led to an emergency use authorization (EUA) of the drug.

As FDA prioritizes encouraging clinical trial diversity, the agency published a blog post about a June meeting it held with the North Carolina Community Health Center Association and the Association of Clinical Research Professionals-Research Triangle Park Chapter in North Carolina, which included members of the Racial and Ethnic Minority Acceleration Consortium for Health Equity (REACH) consortium, to discuss increasing trial participation of people who identify as members of the LGBTQIA+ community. One of the outcomes was that the trial screening processes should include sexual identity and gender identity measures to ensure patients are accurately described in the data.

The Center for Biologics Evaluation and Research (CBER) updated its Standard Operating Policy and Procedure (SOPP) on how staff plan to assign proper names and suffixes to biologics and drugs. The agency noted the latest update removes certain unnecessary and unclear information while reorganizing the contents of the document and updating definitions.

CBER's Office of Therapeutic Products (OTP) is hosting a virtual town hall on 5 September to answer questions about the development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs). Stakeholders can submit written questions to be answered during the town hall meeting until 6 August, but the agency will also take questions during the presentation.

FDA renewed several advisory committees this week for two more years, including its Pharmacy Compounding Advisory Committee, Psychopharmacologic Drugs Advisory Committee, Anesthetic and Analgesic Drug Products Advisory Committee, and Drug Safety and Risk Management Advisory Committee.

Drugs & Biologics

FDA this week adopted the International Council for Harmonisation (ICH) M12 guideline on drug interaction studies, as well as a companion M12 question-and-answers guidance.

The agency expanded the indication for Janssen's cancer drug combination Darzalex (daratumumab) and Faspro (hyaluronidase-fihj) in combination with bortezomib, lenalidomide, and dexamethasone to treat patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The combo was previously approved to treat other forms of multiple myeloma.

FDA also approved a new indication for GSK's Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel, followed by treatment with Jemperli alone, for adult patients with primary advanced or recurrent endometrial cancer (EC). The drug combination had already been approved to treat primary advanced or recurrent EC that is mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) after treatment with Jemperli alone.

FDA has granted accelerated approval to Adaptimmune's gene therapy Tecelra (afamitresgene autoleucel) to treat adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and meet certain qualifications. The agency noted that it was the first gene therapy approved to treat adults with metastatic synovial sarcoma. The drug was also granted Regenerative Medicine Advanced Therapy designation, priority review, and orphan drug designation.

Medtech

FDA announced granting de novo authorization to several products this week. They include Terragene's Bionova Photon Biological Indicator (BT225) and Bionova Photon Auto-Reader Incubator (BPH); GT Metabolic's MagDI System; DiaSorin Molecular's Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, and Simplexa C. auris Sample Prep Kit; and Tulavi Therapeutics' allay Nerve Cap.

FDA also said it has reevaluated the Clinical and Laboratory Standards Institute's (CLSI) M100 (MIC) standard and now recognizes it as a valid diagnostic for E. faecium and Enterococcus spp. (other than E. faecium) when considering using daptomycin injections. In 2020, the agency recognized the daptomycin breakpoints for Enterococcus faecalis but did not recognize breakpoints for E. faecium.

Guardant Health announced that FDA had approved its Shield blood test as the first primary test to diagnose colorectal cancer. The company also noted that Medicare will cover the blood-based test so that beneficiaries can be tested every three years.

FDA and Health Canada have issued a safety alert to healthcare providers about Megadyne's Mega 2000 and Mega Soft Patient Return Electrodes. The electrodes have been recalled since 2023 after reports that patients were getting burned by them during monopolar electrosurgery, and the regulatory agency has warned that electrodes with product code 0840 should not be used, and certain other electrodes should only be used on patients 12 years and older.

CDRH announced it had published two web pages for healthcare facilities that reprocess single-use medical devices. The first page details the agency's regulatory policies regarding product oversight, and the second page is a question-and-answer page that tries to answer some of the most frequently asked questions about the topic.

This Week at FDA: FDA seeks new CDRH director, new oncology approvals, ICH M12 adopted

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