Pharmacyclics (PCYC) announced that the FDA will review its supplemental New Drug Application (sNDA), seeking full approval of Imbruvica for treating patients with chronic lymphocytic leukemia (CLL.TO) and small lymphocytic lymphoma (:SLL) who have been treated at least once before for the disease, on a priority basis.
A decision from the U.S. regulatory body should be out by Oct 7, 2014. Shares of the company reacted positively to the news. The application was filed in April this year.
Pharmacyclics filed the application on the basis of positive data from a head-to-head, phase III study (RESONATE: n=391) on Imbruvica as a monotherapy versus GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) for treating the above mentioned patient population. Pharmacyclics has a partnership on Imbruvica with Janssen (a Johnson & Johnson (JNJ) company).
According to a planned interim analysis of the randomized, multicenter, open-label study, conducted in Jan 2014, patients treated with Imbruvica as a monotherapy exhibited statistically significant improvement in progression free survival as well as overall survival compared to those treated with Arzerra alone.
We note that the FDA granted accelerated approval to Imbruvica as a monotherapy for the CLL/SLL indication in Feb 2014. Accelerated approval for the indication was gained on the basis of the overall response rate (ORR.V) of patients in a phase Ib/II study, which did not establish improvements in survival or disease-related symptoms following Imbruvica treatment.
Gaining the FDA nod, as far as full approval for the CLL/SLL indication is concerned, should be a mere formality for Pharmacyclics / Johnson & Johnson in view of the highly impressive data from the RESONATE study.
Pharmacyclics also received accelerated approval for Imbruvica as a monotherapy in the mantle cell lymphoma (:MCL) indication late last year. Approval was gained for treating MCL patients who have been treated at least once for the disease.
Accelerated approval is granted by the FDA to drugs that are meant to treat serious conditions and fulfill an unmet medical need based on a surrogate or an intermediate clinical endpoint. Pharmacyclics is also developing Imbruvica in other oncology indications.
Pharmacyclics carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) on the other hand holds a bullish Zacks Rank #1 (Strong Buy).