Pfizer's Kidney Cancer Drug Gets Acceptance in the U.S. & EU
Pfizer Inc. PFE announced encouraging news with the FDA and the European Medicines Agency (EMA) accepting the company’s regulatory submission for label expansion of its cancer drug, Sutent (sunitinib).
The company is looking to expand Sutent’s label for adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) after surgery. There is currently no approved therapy for patients with kidney cancer post surgery.
The company’s supplemental biologics license application (sBLA) for Sutent has been received by FDA with a response expected to be out by Jan 2018. The EMA has validated a type II variation application for SUTENT in the same patient population. The validation marks the initiation of the EMA’s centralized review process.
Notably, Sutent is already sanctioned for advanced RCC, imatinib-resistant or intolerant gastrointestinal stromal tumors and advanced pancreatic neuroendocrine tumors.
Shares of Pfizer climbed more than 1% in pre-market trading. However, the same has underperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has gained 0.7% during the period, compared to the broader industry’s increase of 10.7%.
The regulatory submissions are supported by positive result from a phase III S-TRAC, (Sunitinib Trial in Adjuvant Renal Cancer) study. The randomized, double-blind trial evaluated Sutent in comparison to placebo in the adjuvant setting in patients who are at high risk of renal cell carcinoma (RCC). Importantly, the S-TRAC trial has two cohorts: Global and China. These results are reported from the Global cohort, while finds from the China cohort will be reported at a later date as they are yet to mature.
Per company’s information, RCC is the most common type of kidney cancer, accounting for around 90% of all kidney cancers. Nearly 338,000 new cases of kidney cancer are reported worldwide which represents approximately 2-3% of all cancers. Hence there is a huge market opportunity to cater to the unmet needs of patients, affected with the disease worldwide.
Sad but true, the RCC market is already pretty crowded. Significantly, the FDA had approved Exelixis, Inc.’s EXEL Cabometyx in Apr 2016 for treatment of advanced RCC in patients who received prior anti-angiogenic therapy. In Nov 2015, the FDA approved Bristol-Myers Squibb’s BMY Opdivo for the same indication.
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Zacks Rank & Key Picks
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in healthcare sector is VIVUS, Inc. VVUS which flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’s loss per share estimates slashed from 50 cents to 39 cents for 2017 in the last 30 days. The company posted positive earnings surprises in all four trailing quarters with average beat of 233.69%.
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