October 2011 | Volume 10 | Issue 10 | Features | 1215 | Copyright © October 2011
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
Zelboraf Receives FDA Approval
Roche has announced that the FDA approved ZelborafTM (vemurafenib)
for the treatment of BRAF V600E mutation-positive,
inoperable or metastatic melanoma, as well as the cobas 4800
BRAF V600 Mutation Test, a diagnostic test developed by Roche
to identify patients eligible for treatment. ZelborafTM is the first
FDA-approved personalized medicine shown to improve survival
in people with BRAF V600E mutation-positive metastatic melanoma.
It is designed to target and inhibit some mutated forms of the
BRAF protein found in about half of all cases of melanoma.
The FDA approval of ZelborafTM is based on results from two
clinical studies (BRIM3 and BRIM2) in people with BRAF V600E
mutation-positive, inoperable or metastatic melanoma as determined
by the cobas BRAF Mutation Test. BRIM3 is a global,
randomized, open-label, controlled, multicenter, Phase III study
that compared ZelborafTM to dacarbazine chemotherapy, a standard
of care, in 675 patients with previously untreated BRAF
V600E mutation-positive, unresectable (inoperable) or metastatic
melanoma. The endpoints of BRIM3 were overall survival (OS) and
investigator-assessed progression-free survival (PFS). Other endpoints
included confirmed investigator-assessed overall response
rate. BRIM2 is a global, single-arm, multicenter, open-label Phase
II study that enrolled 132 patients with previously treated BRAF
V600E mutation-positive, unresectable or metastatic melanoma.
The primary endpoint of BRIM2 was confirmed overall response
rate as assessed by independent review.
ZelborafTM will be available in the United States within two weeks
of approval. Roche has also submitted new drug applications for
ZelborafTM in the EU, Switzerland, Australia, New Zealand, Brazil,
India, Mexico, and Canada. While Roche seeks regulatory approval
of ZelborafTM in other countries, a global Expanded Access
Program (EAP) is available for people with previously treated or
untreated BRAF V600 mutation-positive metastatic melanoma.
FDA Bans Skin Whitening Products
The FDA recently banned 23 skin whitening products for exceeding
the national regulatory limit of 1 ppm for mercury in
cosmetics, expanding the list of proscribed products to 50.
Eleven of these 50 were tested recently by the EcoWaste Coalition,
a toxic watchdog group, and were found to contain
mercury from 1,085 ppm to 28,600 ppm.
According to the FDA advisory signed by Director Suzette Lazo,
the banned items “pose imminent danger or injury to the consuming
public and the importation, selling, or offering for sale of
such is a violation of Republic Act 9711 or the FDA Act of 2009.”
Psoriasis Drugs Not Linked to Increased
In response to recent clinical trials, which have linked a subclass
of biologics used to treat psoriasis, including ustekinumab (Stelara® ) and briakinumab, to an increased risk of heart attack and
stroke, a study out of Baylor Research Institute suggests there is
no such link. The study, published in the Journal of the American
Medical Association, analyzed previous research and found
no measurable evidence that Stelara® or briakinumab harm the
heart, although the researchers caution that more extensive
studies will be needed to confirm this conclusion because the
pool of patients was too small to draw firm conclusions, and because
none of the clinical trials lasted more than 12 weeks.
The FDA has approved Stelara® for psoriasis patients, but briakinumab
is not yet available. The FDA does not require Stelara® or any
other approved biologic to carry a warning about cardiovascular risk.
Taenda Luxe Device for Treatment of Periorbital
Wrinkles at Home
Syneron Beauty has announced that it has received 510(k)
clearance from the FDA to market the new TaendaTM Luxe Light
Emitting Diode device to consumers. The new device is a nextgeneration
evolution of the Taenda Regenerate, and is cleared by
the FDA for over-the-counter treatment of wrinkles, rhytides and
fine lines around the periorbital region. Syneron Beauty expects
to begin commercialization of the Taenda Luxe wrinkle treatment
device in the fourth quarter.
The Safe Cosmetics Act of 2011
A new bill, titled the Safe Cosmetics Act of 2011 (H.R.2359), that
was recently introduced in the U.S. House of Representatives aims
to ensure that all personal care products are safe by establishing a
system to assess the safety of cosmetics ingredients and to phase
out the most harmful substances that are suspected of causing
cancer, reproductive harm, or other adverse health effects.
The Act requires companies to provide existing safety data on
the cosmetic ingredients they are using to the FDA. It also requires
suppliers of cosmetic ingredients to make available to
manufacturers purchasing those ingredients a full listing of the
chemicals in fragrance and preservatives and information regarding
the toxicological properties and the safety — including
any safety tests they've conducted — of those ingredients.