The U.S. FDA accepted Novocure GmbH’s premarket approval (PMA) application to use its Tumor Treating Fields (TTFields) technology together with standard systemic therapies to treat non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy. Novocure hopes that the application, under review, will get the green light and the therapy, which uses electric fields to disrupt solid tumors and kill cancer cells, will be on the market in the second half of 2024.

In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.

The U.S. FDA granted premarket approval to Avita Medical Inc.’s Recell system for a wide range of full-thickness skin defects, potentially quintupling the company’s market opportunity. Recell is a cell harvesting device that produces and delivers a regenerative cell suspension using a small sample of the patient’s own skin. The Spray-On Skin cells, previously approved for use in severe burns, stimulate healing and repigmentation. “This is a landmark approval representing an inflection point for Avita Medical,” said Avita CEO Jim Corbett. “The FDA approval now offers surgeons a best-in-class treatment option for a multitude of severe wounds within inpatient and outpatient settings.”