- 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).
at Zacks.com (Jan 23, 2015)