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Teva's Synribo gets FDA approval
JERUSALEM — Teva Pharmaceutical Industries on Thursday announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.
The drug is indicated for adult patients with chronic phase or accelerated phase chronic myeloid leukemia with resistance and/or intolerance to two or more tyrosine kinase inhibitors.
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Janssen Biotech: Second indication won for cancer drug Imbruvica
HORSHAM, Pa. — Janssen Biotech on Wednesday announced the Food and Drug Administration has approved Imbruvica (ibrutinib) capsules for the treatment of patients with chronic lymphocytic leukemia who have received at least one prior therapy. Imbruvica was first approved in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Both indications are based on an overall response rate. An improvement in survival or disease-related symptoms has not been established.