The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA approval of Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia.
FDA approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma.
Eisai and Merck said the European Commission granted a marketing authorization for the oral receptor tyrosine kinase inhibitor Lenvima (lenvatinib), as a single agent for the first-line treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapy.
FDA approved pembrolizumab (Keytruda) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
FDA has updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq, as described below.
FDA granted an accelerated approval to nivolumab (Opdivo) for patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy.
Kyowa Hakko Kirin Co. Ltd. said FDA has granted approval for Poteligeo (mogamulizumab-kpkc) for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. FDA granted Priority Review and Breakthrough Therapy Designation in late 2017.
FDA approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of adults and adolescents age 12 and older with pheochromocytoma or paraganglioma that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.
TheraBionic GmbH, a German company co-founded by Boris Pasche, director of the Wake Forest Baptist Comprehensive Cancer Center, and Alexandre Barbault, co-inventor of the TheraBionic technology, has received European regulatory approval for its TheraBionic P1 medical device for use in the treatment of advanced hepatocellular carcinoma.
Merck said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Keytruda, Merck's anti-PD-1 therapy, in combination with pemetrexed (Alimta) and platinum chemotherapy (cisplatin or carboplatin) for the first-line treatment of metastatic nonsquamous non-small cell lung cancer in adults whose tumors have no EGFR or ALK genomic tumor aberrations, regardless of PD-L1 expression.
