On the basis of results from the Phase 3 RESONATE clinical trial, Pharmacyclics (PCYC) files a supplemental NDA for its oral kinase inhibitor IMBRUVICA as a single therapeutic agent for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least one prior therapy.
The trial compared IMBRUVICA (ibrutinib) to ofatumumab in 391 patients. Patients treated with IMBRUVICA alone showed a statistically significant improvement in the secondary endpoint of overall survival.
The FDA granted accelerated approval status for the product as a single agent for the treatment of the cancers cited above.
The company's development and commercialization partner is Janssen Biotech (JNJ).