NEW YORK – The Scottish Medicines Consortium this week accepted two targeted therapies for use within the National Health System Scotland. AstraZeneca's osimertinib (Tagrisso) was accepted for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer with activating EGFR mutations, based on data from the FLAURA Phase III trial that showed a median overall survival on osimertinib of 38.6 months for these patients. The SMC also accepted Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan (Enhertu) for patients with HER2-positive unresectable or metastatic breast cancer who have received two or more prior anti-HER2 based therapies, based on data from the Phase II DESTINY-Breast01 trial that showed a response rate of 61.4 percent and a median duration of response of 20.8 months.
Orgenesis said this week that it has expanded its point-of-care network POCare by constructing a cell therapy manufacturing facility in collaboration with Johns Hopkins University. The facility, dubbed the Maryland Center for Cell Therapy Manufacturing, is partially funded through a $5 million grant from the state of Maryland and will enable Johns Hopkins clinicians and researchers to produce cell therapies at the point of care as opposed to shipping cells out to third-party manufacturing facilities. Orgenesis will also be able to connect its Orgenesis Mobile Processing Units and Labs, or OMPULs, with the new facility to increase capacity and manufacturing turnaround time. Orgenesis expects that the first OMPUL in Maryland will deploy during the second half of this year and that the full facility will be operational during the second half of 2023.
The Japan Ministry of Health, Labor, and Welfare this week approved Amgen's KRAS inhibitor sotorasib (Lumakras) to treat KRAS G12C-mutated, unresectable, advanced or recurrent non-small cell lung cancer that has progressed after systemic anticancer therapy. The approval was based on data from the Phase II CodeBreaK 100 trial in NSCLC. That study showed a 37 percent response rate in 123 evaluable patients, including 10 Japanese patients. The approval makes sotorasib the only KRAS inhibitor approved in Japan. Sotorasib was approved for the same indication in the US and Europe last year.
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.