Seven recent FDA actions in dermatology

Recent FDA actions reported on Healio.com/Dermatology have included the agency expanding the approval of Opdivo plus Yervoy for all patients with unresectable or metastatic melanoma, regardless of BRAF V600 mutational status.

Other actions have included the acceptance of Valeant Pharmaceuticals’ biologics license application for brodalumab for treating psoriasis and a warning that laser pointers being misused as toys can cause eye and skin damage:

FDA expands approval of Opdivo plus Yervoy for melanoma

The FDA expanded the approval of nivolumab plus ipilimumab to include all patients with unresectable or metastatic melanoma, regardless of BRAF V600 mutational status.

Jedd D. Wolchok

“The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” Jedd D. Wolchok, MD, PhD, chief of the Melanoma and Immunotherapeutics Service at Memorial Sloan Kettering Cancer Center, said in a press release. Read more

FDA approves Keytruda for first-line treatment of metastatic melanoma

The FDA expanded the approval of the anti–PD-1 immunotherapy pembrolizumab to include first-line treatment of metastatic melanoma.

The FDA in 2014 granted accelerated approval to pembrolizumab (Keytruda, Merck) for treatment of patients with metastatic melanoma who no longer responded to ipilimumab (Yervoy, Bristol-Myers Squibb), an anti–CTLA-4 antibody that has become the standard first-line therapy for metastatic melanoma. Read more

FDA accepts BLA for brodalumab for plaque psoriasis

The FDA has accepted to review the biologics license application for brodalumab for patients with moderate-to-severe plaque psoriasis, according to a press release from Valeant Pharmaceuticals International. Read more

FDA accepts Amgen’s biologics license application for biosimilar to adalimumab

Amgen announced in a press release that the FDA has accepted its biologics license application for ABP 501, Amgen’s biosimilar to adalimumab, for review.

The application was submitted following results from phase 3 comparative studies of patients with rheumatoid arthritis and plaque psoriasis treated with either ABP 501 or AbbVie’s originator adalimumab, Humira. Read more

FDA warns that laser pointer misuse can cause eye, skin injuries

The FDA has issued a warning to consumers and physicians about the risk for eye and skin injuries from products that include lasers, according to a MedWatch safety alert.

Some laser products, including hand-held laser pointers, are being misused as toys, according to the alert. Read more

FDA grants 510(k) clearance for SebDerm Gel for seborrheic dermatitis

Oculus Innovative Sciences announced in a press release that the FDA has granted 510(k) clearance for it Microcyn-based SebDermGel to treat seborrheic dermatitis.

“Seborrheic dermatitis is a common condition affecting men and women of all ages that is challenging for dermatologists to treat,” Zoe Draelos, MD, president of Dermatology Counseling Services in High Point, North Carolina, stated in the release. “A new addition to the dermatologist’s armamentarium, such as Microcyn technology, will be welcome.” Read more

FDA approves Omnigraft for diabetic foot ulcers

The FDA recently expanded the indication for the Integra Omnigraft Dermal Regeneration Matrix for the treatment of certain diabetic foot ulcers, according to a company press release.

The device is used by placing it over the ulcer to provide an environment for new skin and tissue to regenerate and help heal the wound. Read more