Eli Lilly and Co. said FDA has granted Priority Review designation for its New Drug Application for Verzenio (abemaciclib), a cyclin-dependent kinase (CDK) 4 & 6 inhibitor.
Boehringer Ingelheim said the supplemental New Drug Application for Gilotrif (afatinib) has been accepted for filing and granted Priority Review by FDA. The application for Gilotrif is currently under review for first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 21 (L861Q), G719X, or S768I substitution mutations as detected by an FDA-approved test.
Janssen Biotech Inc. said it has submitted a New Drug Application to the FDA for apalutamide, an investigational, next generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA approved treatments for patients with non-metastatic CRPC.
FDA has cleared the first seven tesla (7T) magnetic resonance imaging device, more than doubling the static magnetic field strength available for use in the U.S.
Takeda Pharmaceutical Co. Ltd. said FDA has approved the supplemental new drug application for Alunbrig (brigatinib) 180 mg tablets.
Genentech, a member of the Roche Group, said FDA has accepted the company's supplemental Biologics License Application and granted Priority Review for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer.
Mylan N.V. announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec Tablets.
Amgen and CytomX Therapeutics Inc. have entered into a collaboration in immuno-oncology that will allow the companies to co-develop a CytomX Probody T-cell engaging bispecific against the epidermal growth factor receptor. Probody T-cell engaging bispecifics are antibody constructs capable of directing cytotoxic T-cells in tumor microenvironments. In preclinical studies, CytomX’s Probody versions of EGFRxCD3 bispecific […]
Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient's hormones. Verzenio, sponsored by Eli Lilly, is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread.
