Debiopharm International and ImmunoGen, Inc. announced that Debiopharm has acquired ImmunoGen's IMGN529/DEBIO 1562, a clinical-stage anti-CD37 ADC for the treatment of patients with B-cell malignancies, such as non-Hodgkin lymphomas.
The FDA Oncology Center of Excellence has begun a podcast series called “Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)” about new product approvals, emerging safety information for cancer treatments, and other topics in cancer drug development.
FDA granted regular approval to Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended approval of expanding the use of Zykadia (ceritinib) to include the first-line treatment of patients with advanced non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive.
FDA has approved Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.
FDA granted accelerated approval to avelumab (trade name Bavencio) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
FDA has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in postmenopausal women.
The European Commission has approved the antibody ch14.18/CHO, dinutuximab beta, for the treatment of high-risk neuroblastoma in patients aged 12 months and above.
FDA granted Fast Track designation for Reolysin, an immuno-oncology viral agent, for the treatment of metastatic breast cancer.
The European Medicines Agency granted orphan drug designation to PIQUR's lead compound PQR309 for the treatment of patients with diffuse large B-cell lymphoma.
