FDA approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, as detected by an FDA-approved test.
Advaxis, Inc. and Bristol-Myers Squibb announced a clinical development collaboration to evaluate ADXS-DUAL, an investigational immunotherapy targeting HPV-associated cancers, and Bristol-Myers Squibb's PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), as a potential combination treatment option for women with metastatic cervical cancer.
The Johns Hopkins University and Eisai Inc. have extended their drug discovery collaboration through a licensing agreement.
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.
In an unprecedented, fast-tracked review, FDA granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature.
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.