Novartis (NVS) announced that the FDA has approved its ARZERRA (ofatumumab), in combination with the chemo agents fludarabine and cyclophosphamide, for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). ARZERRA was previously approved for the treatment of CLL patients who have not responded to fludarabine and Sanofi’s (SNY) LEMTRADA (alemtuzumab), in treatment-naive CLL patients not treated with fludarabine and maintenance treatment of CLL in partial/complete responders treated with at least two prior lines of therapy.
Pfizer (PFE) announced that the European Commission (EC) has approved the use of its XALKORI (crizotinib) for the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors are ROS1 mutation-positive. XALKORI was previously approved in the EU for the first/second line treatment of NSCLC that expresses the enzyme anaplastic lymphoma kinase (ALK).
Ignyta (RXDX) announced that the FDA has approved its IDE (investigational device exemption) for its companion diagnostic next-generation sequencing (NGS) assay, Trailblaze Pharos. The company intends to use it to identify patients with NTRK1/2/3-, ROS1- or ALK-positive solid tumors to determine eligibility in its Phase 2 STARTRK-2 clinical trial evaluating lead product candidate entrectinib in a range of cancers, particularly non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).