NEW YORK – Gilead Sciences said this week that the US Food and Drug Administration has granted full approval for sacituzumab govitecan-hziy (Trodelvy) for previously treated, unresectable, locally advanced or metastatic triple-negative breast cancer. The agency previously granted accelerated approval to the Trop-2 directed antibody drug conjugate — a product of Gilead subsidiary Immunomedics — for this indication based on response rates observed in a Phase II trial. The decision to convert the accelerated approval to a full approval is based on the confirmatory Phase III ASCENT trial, in which sacituzumab govitecan-hziy demonstrated overall survival and progression-free survival advantages versus chemotherapy.
Seattle-based Atossa Therapeutics said this week that an ovarian cancer patient has begun receiving its oral endoxifen, the administration of which the US Food and Drug Agency previously granted through the expanded access pathway. The patient, who is receiving treatment at the University of Washington Medical Center, could not tolerate tamoxifen. Subsequently, her tumor was molecularly profiled and a sample was grown in 3D organoid cultures to test treatments she might respond to. "This testing revealed that the combination of endoxifen and alpelisib [Novartis' Piqray] produced an exceptional tumor response," Atossa CEO Steven Quay said in a statement. "We will follow the progress of this patient and consider additional clinical studies in patients with ovarian cancer." Atossa is currently developing endoxifen as a breast cancer treatment that patients can receive between diagnosis and surgical resection, and is planning to report final Phase II data in Q2 2021 and discuss regulatory strategies with the FDA.
The Barbara Ann Karmanos Cancer Institute in Detroit this week announced a partnership with The Toledo Clinic to open a new cancer center in Maumee, Ohio in 2022 with the goal of improving access to precision oncology. The two entities will jointly provide services that involve multidisciplinary clinics, diagnostic imaging, pharmacy, laboratory testing, genetic counseling, and social services. The involvement of Karmanos, a National Cancer Institute-designated comprehensive cancer center, will increase patients' access to investigational drugs through clinical trials and research protocols in northwest Ohio. The new cancer center will utilize telemedicine and auxiliary services, as well as virtual support groups and social services, to expand the reach of care teams into the community. "Our colleagues at The Toledo Clinic share a common vision with the entire team at Karmanos: use the very latest in treatment modalities combined with access to 'bench-to-bedside' clinical trials and precision medicine to achieve the goal of eradicating cancer," said Justin Klamerus, president of the Karmanos Cancer Hospital & Network.
Caris Life Sciences said this week that the Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" has joined its Precision Oncology Alliance, a collaborative network of cancer centers working to advance comprehensive cancer profiling and establish standards of care for molecular testing and personalized treatment strategies. The largest clinical care and cancer research center in Southern Italy, Pascale Foundation, joins nearly 50 other institutions in Caris' alliance. Members can use Caris' database and artificial intelligence platform in patient care and in studies to establish new evidence-based standards. Alliance members can also access a growing portfolio of biomarker-directed trials sponsored by pharmaceutical companies.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.