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Pfizer's Cancer Drug Sutent Gets FDA Nod for Label Expansion

Pfizer Inc. PFE announced that the FDA has approved a label expansion for its cancer drug Sutent (sunitinib malate). With this latest approval, Sutent’s label has been expanded as an adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (“RCC”) following surgery. This approval makes it the first and only adjuvant therapy for recurrent RCC, the most common type of kidney cancer.

Sutent is marketed for the first-line treatment of advanced renal cell carcinoma (RCC).

We remind investors that the supplemental new drug application (sNDA) for the drug was accepted by the FDA earlier in May. Subsequently, in September, the drug’s label for the expanded indication got a mixed response from the FDA’s Oncologic Drug Advisory Committee (ODAC). The committee voted six in favor and six against the benefit-risk profile for Sutent for the expanded indication. However, the drug’s label expansion was approved earlier than the target action date in January 2018.

Pfizer’s shares have underperformed the industry so far this year. The stock has gained 9.5%, comparing unfavorably with the industry’s 14.7% rally during the period.

Notably, the FDA approval was based on positive data from a phase III study (S-TRAC), evaluating Sutent as an adjuvant treatment in patients at high risk of recurrent RCC, following nephrectomy (surgical removal of the cancer-containing kidney). Full data presented in October last year, showed that the trial met the primary endpoint of improving disease-free survival (“DFS”), determined by a blinded independent central review in such patients. Data demonstrated that Sutent extended DFS by 6.8 years compared with 5.6 years in the placebo arm, resulting in an overall risk reduction of 24%.

An application for use in the same patient population is also under review in the EU.

Significantly, the kidney cancer market is already pretty crowded. The drug faces stiff competition from Bristol-Myers Squibb's BMY Opdivo, Novartis' NVS Afinitor and Votrient, Bayer's and Amgen's Nexavar, Roche’s RHHBY Avastin and Tecentriq among others.

Sutent generated sales of $805 million year to date, down 2% year over year due to competitive pressure. However, with this approval for the expanded patient population, sales of the drug should improve.

Per information provided by the company, RCC accounts for around 90% of all kidney cancers. Also, those at high risk of recurrence represent approximately 15% of all patients. It is estimated that 60% of high-risk patients will have RCC recurrence within five years. Hence, the potential market opportunity for the drug is huge for this additional indication.

Zacks Rank

Pfizer carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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