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.
Novartis said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
Eisai Co. Ltd. and Merck said FDA granted Breakthrough Therapy designation for Lenvima (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed following at least one prior systemic therapy.
Trazimera, a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, received European Commission approval.
FDA approved Magtrace and Sentimag Magnetic Localization System (Sentimag System), a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. It uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.
