Novartis entered into a collaboration and license agreement with Xencor Inc. to develop and commercialize novel therapeutics, including XmAb 14045 for acute myeloid leukemia, and XmAb 13676 for B-cell malignancies. Both are expected to begin development this year. Under the terms of the agreement, the parties will collaborate and share development costs for the worldwide […]
Hetero launched a biosimilar of bevacizumab in India for the treatment of metastatic colorectal cancer under the brand name Cizumab. The product has been approved by the drug controller general of India and has been recommended as a first-line treatment for mCRC. The product will be made available to patients in a single dose vial […]
FDA granted Fast Track Designation to ets-family inhibitor TK216 in Ewing sarcoma patients that have relapsed or are refractory to standard of care therapy. Oncternal Therapeutics Inc., the drug’s sponsor, is in the process of initiating a first-in-human phase I trial in relapsed or refractory Ewing sarcoma. TK216 is a first-in-class small molecule that inhibits […]
FDA approved Epclusa to treat adult patients with chronic hepatitis C virus both with and without cirrhosis. For patients with moderate to severe cirrhosis, Epclusa is approved for use in combination with the drug ribavirin.
FDA granted a fourth Breakthrough Therapy Designation to Imbruvica (ibrutinib) as a potential treatment of chronic graft-versus-host-disease after failure of one or more lines of systemic therapy. The agency also granted the therapy Orphan Drug Designation for the condition. The request was based on preliminary clinical data from a phase Ib/II study evaluating the safety […]
FDA approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the cancer drug Tarceva (erlotinib). This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor gene mutations in non-small cell lung cancer patients.
Genomic Health Inc. launched Oncotype SEQ Liquid Select, the first of several non-invasive liquid biopsy tests that the company plans to deliver through its Oncotype IQ Genomic Intelligence Platform. Oncotype SEQ is a blood-based test that identifies and assesses actionable genomic alterations in a panel of 17 select genes to inform the treatment of stage... […]
The Canadian Agency for Drugs and Technologies in Health made a positive recommendation for Opdivo (nivolumab) for the treatment of non-small cell lung cancer. The CADTH evaluation of Opdivo was made under the pan-Canadian Oncology Drug Review process.
FDA granted Orphan Drug Designation to Debio 1143 for the treatment of ovarian cancer. Debio 1143 is an oral, small molecule inhibitor with a dual pro-apoptotic and immunomodulatory mode of action developed as a chemo/radio-sensitizer, according to Debiopharm International SA, the drug’s sponsor. Debiopharm plans to expand the clinical development of this therapy to patients... […]
FDA granted Priority Review to oral telotristat etiprate for the treatment of carcinoid syndrome. The agency has set a target action date of Nov. 30. Telotristat etiprateis sponsored by Lexicon Pharmaceuticals Inc. Telotristat etiprate targets tryptophan hydroxylase, an enzyme that triggers the excess serotonin production within mNET cells that leads to carcinoid syndrome. Telotristat etiprate... […]
