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Pharmacyclics submits filing for cancer drug

  • 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).
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