indication may be contingent upon verification and description
of clinical benefit in the confirmatory trials.
Opdivo demonstrated efficacy in a Phase 3, pivotal clinical trial
with advanced melanoma in patients who had been previously
treated and progressed with Yervoy and, if BRAF mutation
positive, a BRAF inhibitor. The efficacy of Opdivo was evaluated
based on a single-arm, non-comparative planned interim analysis
of the first 120 patients who received Opdivo with a minimum
of 6 months follow-up in the Phase 3 CheckMate -037 trial.
Opdivo achieved a 32% (95% CI: 23, 41) response rate (38/120)
with a dosing strength and frequency of 3 mg/kg intravenously
over 60 minutes every 2 weeks. 3% of patients (4/120)
achieved a complete response, and 28% (34/120) achieved a
partial response. Of 38 patients with responses, 33 patients
(87%) had ongoing responses with durability of response
ranging from 2.6+ to 10+ months, which included 13 patients
with ongoing responses of 6 months or longer. Responses to
Opdivo were demonstrated in both patients with and without
BRAF mutation.
The safety profile of Opdivo has been demonstrated in the pivotal,
Phase 3 CheckMate-037 trial. Serious adverse reactions
occurred in 41% of patients receiving Opdivo. Grade 3 and 4 adverse
reactions occurred in 42% of patients receiving Opdivo.
The most frequent Grade 3 and 4 adverse drug reactions reported
in 2% to <5% of patients receiving Opdivo were abdominal
pain, hyponatremia, increased aspartate aminotransferase, and
increased lipase. The most common adverse reaction (≥20%)
reported with Opdivo was rash (21%).
CheckMate -037 was a randomized, Phase 3 trial evaluating
Opdivo 3 mg/kg (n=268), administered every two weeks, or chemotherapy
(n=102) (investigator’s choice of either single-agent
dacarbazine 1000 mg/m2 every 3 weeks or the combination of
carboplatin AUC 6 every 3 weeks plus paclitaxel 175 mg/m2
every 3 weeks) in patients with advanced melanoma who had
been previously treated and progressed with Yervoy and, if
BRAF mutation positive, a BRAF inhibitor. No premedication is
required with Opdivo.
The primary objective of this analysis of the CheckMate -037
trial was Objective Response Rate (ORR). CheckMate -037 included
90 participating trial sites in 14 countries, and included
both institutional and community practice centers. The clinical
study is ongoing to determine whether there is an overall
survival benefit.
In the Opdivo treated patients (n=120), 76% of patients had
M1C disease, 18% of patients had a history of brain metastases,
and 56% of patients had elevated LDH levels. The median
age of patients was 58. 22% of patients were BRAF V600 mutation
positive.
Valeant Introduces AMBI Even & Clear CC+ Even Tone Environmental Shield
Valeant introduced the NEW AMBI® EVEN & CLEAR CC+ CREAM
Even Tone Environmental Shield – the first color product in the
AMBI® Skincare Line. Specially formulated to match the rich
tones of women of color, this CC+ Cream contains argan oil,
shea butter, and antioxidants to moisturize the skin.
AMBI® CC+ Cream provides broad-spectrum SPF 30 sunscreen
protection from UV sun rays that can accelerate the formation
of fine lines and wrinkles. This sunscreen is formulated not to
leave the skin looking ashy or gray. “The addition of SPF 30 is
significant,†explains Dr. Dryer, “because many CC creams offer
sunscreen with only SPF 20 and may leave a chalky residue
on the skin. AMBI® CC+ Cream provides a higher level of sun
protection with quality pigments, without sacrificing a luxurious
feel and great coverage."
Available in Light/Medium and Medium/Dark, AMBI® CC+
Cream is designed to even skin tone instantly with soft focus
technology, while helping to shield your skin from environmental
elements that may cause uneven skin tone, dry out the skin,
and accelerate fine lines and wrinkles. AMBI® EVEN & CLEAR
CC+ Cream Even Tone Environmental Shield will be available
at national mass, drug, and beauty supply retail stores in March
2015 with an SRP of $8.99.
