Bristol-Myers Squibb’s Opdivo + Yervoy Regimen Receives Expanded FDA Approval
The FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This approval expands the original indication for the Opdivo + Yervoy Regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which PFS and overall survival (OS) were co-primary endpoints.
The FDA also expanded the use of Opdivo as a single-agent to include previously untreated BRAF mutation-positive advanced melanoma patients. The use of Opdivo as a single-agent in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Opdivo was approved by the FDA in November 2015, for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma.
Novartis Teams with Pro Football Hall of Famer Troy Aikman on Melanoma Education
Troy Aikman, diagnosed with stage II melanoma in 1998, has teamed up with Novartis for the Melanoma Just Got Personal campaign. The campaign has created personalized markings to show the different mutations of melanoma. Campaign partners are asking patients and supporters to show their strength, resolve and knowledge by sharing a photo of themselves wearing the marking that represents their particular form of advanced melanoma.
Melanoma Just Got Personal was developed in collaboration with melanoma patient advocacy organizations including AIM at Melanoma Foundation, the Melanoma International Foundation, and the Melanoma Research Foundation.
New Sunscreen Blocks UV Rays, Boosts Vitamin D
A new sunscreen— Solar D—may do more than block ultraviolet radiation, it may also allow the body to produce vitamin D, according to a study in PLOS ONE. Solar D is currently available in Australia and will be available in the US in summer 2016.
There are several chemical compounds that are typically used in a sunscreen that efficiently absorbed varying wavelengths of UVB radiation. After removing certain ingredients, researchers compared Solar D, which has an SPF of 30, to a popular commercial sunscreen with the same SPF, and found Solar D allowed for up to 50 percent more production of vitamin D in-vitro.
Women Diagnosed with Melanoma Under 40 Indoor Tanned Earlier
Melanoma among younger individuals is on the rise, and now new research suggests that initiating indoor tanning at an earlier age and more frequent tanning may be to blame. In the study, published online in JAMA Dermatology, women younger than 40 when diagnosed with melanoma reported initiating indoor tanning at an earlier age and more frequent tanning than older women diagnosed with the skin cancer.
The study included 681 patients from Minnesota diagnosed with melanoma between 2004 and 2007 and 654 comparison patients aged 25 to 49. Among the patients with melanoma, 68.3 percent were women as were 68.2 percent of the patients in the comparison group. Women who tanned indoors had between a two times to six times increased risk of developing melanoma. Compared with women 40 to 49, women younger than 40 reported initiating indoor tanning at a younger age (16 vs. 25 years old) and they reported more frequent indoor tanning (median number of session, 100 vs. 40. About 33 percent of the women (21 participants) diagnosed before the age of 30 had melanomas on their trunk compared with 24 percent of women (64 participants) who were 40 to 49. All but two of the 63 youngest women in the group of women diagnosed with melanoma reported tanning indoors.
Men were less likely to report indoor tanning use compared with women (44.3 percent vs. 78.2 percent), regardless of whether the men were diagnosed with melanoma or were comparison patients, which may explain the inconclusive findings for indoor tanning and melanoma among men. Still, among men 30 to 39, about 41 percent were diagnosed as having melanoma on their trunk compared with 49 percent of men age 40 to 49, the study showed. n