Pharmacyclics, Inc. (PCYC) submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for its oncology drug, Imbruvica.
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 patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who had received at least one prior therapy. 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. The drug was found to be safe with a favorable benefit risk profile according to the interim analysis.
We note that the U.S. Food and Drug Administration (FDA) granted accelerated approval to Imbruvica as a monotherapy for the above CLL/SLL indication in Feb 2014. Accelerated approval for the indication was gained on the basis of the overall response rate (ORR) of patients in a phase Ib/II study which did not establish improvements in survival or disease-related symptoms following Imbruvica treatment.
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 endpoint. Pharmacyclics is also developing Imbruvica in other oncology indications.
Pharmacyclics, a biopharmaceutical company, currently carries a Zacks Rank #2 (Buy). A better-ranked stock in the same sector is Alkermes (ALKS). Alkermes holds a Zacks Rank #1 (Strong Buy).
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment