FDA Approves Cosentyx for Psoriasis
Novartis has announced that the FDA has approved Cosentyx
for the treatment of moderate-to-severe plaque psoriasis
in adult patients who require systemic therapy or phototherapy
(light therapy). According to Novartis, Cosentyx is the
first approved human monoclonal antibody that selectively
binds to interleukin IL-17A.
The FDA approval was based on the positive efficacy and
safety outcomes from 10 phase II and phase III studies which
included over 3,990 adult patients with moderate-to-severe
plaque psoriasis. The Phase III clinical program included four
placebo-controlled studies which examined Cosentyx 300
mg and 150 mg in patients with moderate-to-severe plaque
psoriasis. In these studies, Cosentyx met all primary and key
secondary endpoints, including Psoriasis Area and Severity
Index (PASI) 75 and 90 and Investigator's Global Assessment
modified 2011 (IGA) 0/1 responses, showing significant skin
clearance at week 12. Cosentyx (300 mg) also maintained
its safety profile when compared to Enbrel (etanercept) and
Stelara (ustekinumab).
Cosentyx was also recently approved in the EU for the
treatment of moderate-to-severe plaque psoriasis in adult
patients who require systemic therapy or phototherapy (light
therapy. Cosentyx had previously been approved in Australia
for the treatment of moderate-to-severe plaque psoriasis
and in Japan for the treatment of moderate-to-severe plaque
psoriasis and active psoriatic arthritis.
Novartis reports that it is also evaluating Cosentyx for the
treatment of ankylosing spondylitis and psoriatic arthritis. Regulatory
applications for these indications are scheduled in 2015.
Novartis announces FDA approval for first IL-17A antagonist
Cosentyx(TM) (secukinumab) for moderate-to-severe plaque
psoriasis patients.
Offering a new treatment option for patients, Cosentyx is the
first approved human monoclonal antibody (mAb) that selectively
binds to interleukin IL-17A.
Phase III data demonstrated Cosentyx resulted in clear or
almost clear skin in the majority of patients with moderateto-
severe plaque psoriasis
Cobimetinib and Zelboraf (Vemurafenib) in Advanced Melanoma
Genentech has announced that the FDA has accepted and
granted Priority Review for the company’s New Drug Application
(NDA) for cobimetinib in combination with Zelboraf®
(vemurafenib) for the treatment of people with BRAF V600
mutation-positive advanced melanoma. The FDA will make a
decision on approval by August 11, 2015.
The NDA is based on results of the coBRIM Phase III study,
which showed the MEK inhibitor cobimetinib plus Zelboraf
reduced the risk of disease worsening or death by half in people
who received the combination (hazard ratio [HR]=0.51,
95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with
a median PFS of 9.9 months for cobimetinib plus Zelboraf
compared to 6.2 months with Zelboraf alone. The safety profile
was consistent with a previous study of the combination.
The most common Grade 3 or higher adverse events in the
combination arm included liver lab value abnormalities, elevated
creatine phosphokinase (CPK, an enzyme released by
muscles) and diarrhea. The most common adverse events
seen in the combination arm included diarrhea, nausea,
rash, photosensitivity and lab value abnormalities.
The coBRIM study is an international, randomized, double-blind,
placebo-controlled Phase III study evaluating the safety and efficacy
of 60 mg once daily of cobimetinib in combination with
960 mg twice daily of Zelboraf, compared to 960 mg twice daily
of Zelboraf alone. In the study, 495 patients with BRAF V600
mutation-positive unresectable locally advanced or metastatic
melanoma (detected by the cobas® 4800 BRAF Mutation Test) and
previously untreated for advanced disease were randomized to receive
Zelboraf every day on a 28-day cycle plus either cobimetinib
or placebo on days 1-21. Treatment was continued until disease
progression, unacceptable toxicity or withdrawal of consent.
Investigator-assessed PFS was the primary endpoint. Secondary
endpoints include PFS by independent review committee, overall
response rate, overall survival, duration of response and other
safety, pharmacokinetic and quality of life measures.
There was a higher overall frequency of Grade 3 or higher adverse
events in the combination arm (65 vs. 59 percent), with
close to half of these due to lab value abnormalities (mainly
increased blood levels of liver enzymes and CPK). Common adverse
events (occurring in more than 20 percent) observed at a
