FDA Approval of CIP-ISOTRETINOINCipher Pharmaceuticals Inc. has announced that the FDA has approved AbsoricaTM, Cipher's novel, patented brand formulation of the acne medication isotretinoin, for the treatment of severe recalcitrant nodular acne. Absorica is expected to be launched in the US in fourth quarter of 2012.
Stiefel receives FDA approval of FabiorTM Foam, 0.1%Stiefel has announced that the FDA has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%. It is the only retinoid in a topical foam formulation for the treatment of acne vulgaris in patients 12 years of age and older. The approval of tazarotene foam was based on two multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3 studies conducted in the US and Canada.
Perrigo Receives FDA ApprovalPerrigo Company has announced final approval from the FDA for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole·1®. Gynazole·1® (butoconazole nitrate) vaginal cream, 2%, is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). Perrigo was the first applicant to submit a substantially complete ANDA with a paragraph IV certification and is entitled to 180 days of marketing exclusivity. Perrigo is working exclusively with KV Pharmaceutical Company on a collaboration to launch the product by the end of calendar year 2012.
Anti-PD-1 Immunotherapy BMS-936558 and Phase 1 TrialBristol-Myers Squibb Company has announced interim results from the expanded Phase 1 dose-ranging study 003 (n=296) of its investigational anti-PD-1 immunotherapy (BMS-936558), which showed clinical activity in patients with previously-treated non-small cell lung cancer (NSCLC), metastatic melanoma, and renal cell carcinoma (RCC). Anti-PD-1 is a fully-human antibody that targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1. Objective response rates (ORs) across dose cohorts, as measured by standard RECIST criteria, ranged from 6% to 32% in NSCLC, 19% to 41% in metastatic melanoma, and 24% to 31% in RCC. Most responses were durable.
Drug-related serious adverse events occurred in 11% of patients who received BMS-936558. Drug-related adverse events of special interest, defined as those with potential immunerelated etiology, were sometimes severe and life-threatening.
The data on anti-PD-1 were published in the New England Journal of Medicine and presented at the 48th Annual Meeting of the American Society of Clinical Oncology. Data on a second investigational immunotherapy from Bristol-Myers Squibb, anti-PD-L1 (BMS-936559), were also published in the New England Journal of Medicine and presented at the 48th Annual Meeting of the American Society of Clinical Oncology. BMS-936559 is fully-human antibody that targets one of the immunosuppressive ligands for PD-1, PD-L1, which is often expressed on tumor, stromal and immune cells. Study 003 is a dose-ranging Phase 1 study (n=296) evaluating the safety, antitumor activity and pharmacokinetics of BMS-936558 in patients with advanced melanoma (n=104), non-small cell lung cancer (n=122), renal cell carcinoma (n=34), castration-resistant prostate cancer (n=17) and colorectal cancer (n=19).
Eligible patients were administered BMS-936558 as an intravenous infusion every 2 weeks of each 8-week treatment cycle. Cohorts of three to six patients per dose level (0.1, 0.3, 1.0, 3.0, or 10 mg/kg) were enrolled sequentially. Patients continued treatment less-than or equal to 2 years (12 cycles), unless they experienced complete response, unacceptable toxicity, progressive disease, or withdrew consent. In clinically stable patients, treatment could be continued beyond apparent initial disease progression until confirmed progression, as defined by proposed immune response criteria. Patients with stable disease (SD) or an ongoing OR at the completion of treatment were followed for less-than or equal to 1 year and offered retreatment for one additional year if their disease progressed. Objective response was defined as complete response (CR) or partial response (PR).
Objective responses, as measured by standard RECIST criteria, were observed in patients treated with BMS-936558 across dose cohorts and across the NSCLC (6% to 32%), metastatic melanoma (19% to 41%), and RCC (6% to 32%) tumor types. Most responses were durable with response durations greaterthan or equal to 1 year in 65% of responders with greater-than or equal to one year follow-up.
The spectrum, frequency, and severity of treatment-related adverse events (AEs) were generally similar across tested dose levels. Common drug-related AEs included fatigue, rash, diarrhea, decreased appetite and nausea, with Grade 3 to 4 AEs observed in 14% of patients.