Six recent developments in skin cancer

With today’s announcement that the FDA has approved the combination of Opdivo plus Yervoy for treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma, it’s been a busy time for cutaneous oncology developments.

Other developments have included Health Canada approving Opdivo for treating metastastic melanoma and the FDA granting orphan drug designation to avelumab for Merkel cell carcinoma:

1, Health Canada approves Opdivo for treating metastatic melanoma

Bristol-Myers Squibb announced that Health Canada has approved Opdivo for metastatic melanoma.

The approval by the Health Canada Priority Review process makes Opdivo (nivolumab) the first anti–PD-1 treatment approved for adults with previously untreated cases of BRAF V600 wild-type unresectable or metastatic melanoma, according to a press release. Read more

2. FDA grants orphan drug designation to avelumab for Merkel cell carcinoma

The FDA granted orphan drug designation to the investigational immunotherapy avelumab for the treatment of patients with Merkel cell carcinoma.

Avelumab (MSB0010718C, Merck KGaA and Pfizer) — a fully human monoclonal immunoglobulin G1 antibody that targets PD-L1 — is currently under evaluation in the single-arm, open-label, phase 2 JAVELIN Merkel 200 study that is being conducted in Asia Pacific, Australia, Europe and North America. Read more

3. FDA grants priority review of Opdivo plus Yervoy in previously untreated advanced melanoma

The FDA has accepted a supplemental biologics license application for the Opdivo plus Yervoy regimen to include data from a phase 3 trial of patients with previously untreated advanced melanoma, according to a press release from Bristol-Myers Squibb.

The agency also granted priority review of the application, with a target action date of Jan. 23, according to the release. Read more

4. Provectus to study novel drug combined with Keytruda for stage IV melanoma

Provectus Biopharmaceuticals announced in a press release that it has completed protocol for a phase1b/2 testing of its investigational drug PV-10 in combination with Keytruda in patients with stage IV melanoma.

PV-10 is novel drug that is injected into solid tumors and is undergoing phase 3 testing for patients with stage III melanoma, according to the release. Keytruda (pembrolizumab, Merck) is an immune checkpoint inhibitor approved for treating patients with advanced or unresectable melanoma. Read more

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5. Low-dose, high dose-rate brachytherapy controls acral cutaneous T-cell lymphoma

Low-dose, high dose-rate brachytherapy provided palliation to control cutaneous T-cell lymphoma lesions of the hands and feet, according to recently published study results.

Researchers studied six patients with eight distinct patches, plaques or tumors of cutaneous T-cell lymphoma lesions on the hands and feet recalcitrant to prior standard therapies. Read more

6. AAD dermatologists urge parents to use ABCDEs to check for melanoma

As the new school year has begun, dermatologists from the American Academy of Dermatology are urging the parents to learn the mnemonic for early detection of melanoma to regularly check their skin for signs of skin cancer.

Dermatologists are urging parents to learn the ABCDEs of melanoma: A for asymmetry, in which one half of the mole does not match the other half; B for border irregularity; C for color that varies from one area to another; D for diameter larger than 6 mm or the size of a pencil eraser; and E for evolving, in which a mole or skin lesion looks different than others or is changing in size, shape or color. Read more