FDA approved Gilotrif (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.
The University of Chicago and AbbVie entered into a five-year collaboration in oncology. Initially, both organizations will work together to advance research in several areas of oncology, which could include, among others, breast, lung, prostate, colorectal and hematological cancer. Research projects are chosen by a joint steering committee, comprised of representatives from each organization. AbbVie... […]
FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.
FDA granted priority review for atezolizumab (MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1, as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy. “In a study of atezolizumab in people with previously treated advanced lung cancer,... […]
FDA approved Epi proColon, a blood-based colorectal cancer screening test developed by Epigenomics AG. Epi proColon will be made available in the U.S. under a joint commercialization agreement with Epigenomics partner Polymedco. Epi proColon is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such... […]
The European Commission approved a two-dose schedule for Gardasil 9, for adolescent girls and boys aged 9 to 14, in the 31 countries regulated by the European Medicines Agency.
The University of Chicago and Evelo Biosciences entered into a license agreement to develop and commercialize a microbiome-based cancer immunotherapy. The cancer therapy, developed in the laboratories of UChicago researcher Thomas Gajewski, employs select gut microbes to boost the immune system’s attack on cancer cells and improve the efficacy of anti-cancer drugs. “This is the... […]
Sysmex Inostics, a subsidiary of Sysmex Corp., announced that its OncoBEAM RAS CRC test was granted CE mark approval. The CE mark is a mandatory conformity marking for certain products sold within the European Economic Area. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic... […]
Halaven (eribulin) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, to extend Halaven’s license to include patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease. The opinion is based on phase III data demonstrating a median 7.2 month increase in... […]
FDA granted orphan drug designation for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory acute myeloid leukemia patients for a hematopoietic stem cell transplant. Actinium Pharmaceuticals Inc., iomab-B’s sponsor, plans to begin a phase III trial in 150 relapsed and refractory AML patients over the age of 55. Iomab-B is a radioimmunoconjugate consisting of BC8,... […]
