CAR T-therapies for cancer are now under tighter FDA scrutiny as the agency opens an inquiry regarding reports that some patients who received these cell therapies went on to develop new cases of cancer. The FDA said benefits of these therapies still outweigh their risks, but it is evaluating the need for regulatory action.
A partial clinical trial hold has been lifted from cancer drug emavusertib and Curis has selected a dose to use in Phase 2 testing. The small molecule is being developed as a potential treatment for blood cancers.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
While the lymphoma study is now clear to resume enrolling patients, the status of a partial hold on a separate leukemia study remains unchanged so far. The partial holds were placed on both studies of the Curis cancer drug after a patient death in the leukemia trial.
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.
More than years after its initial approval, Kymriah has shown comparable efficacy and an apparently better safety profile than it demonstrated in the studies that led to its leukemia and lymphoma approvals. Another therapy, made by BMS, is a potential competitor.
ArQule's lead product candidate is a BTK inhibitor, ARQ-531, designed for heavily pretreated patients with leukemias and lymphomas, particularly those whose disease has become resistant to marketed BTK therapies. Phase I data on the drug were also presented Monday.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
The Medicare coverage decision, issued Wednesday evening after a nearly three-month delay, removes several requirements that some had feared would limit access to the cell therapies, while also allowing for some off-label use.
The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.
The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
The company presented Phase I data from its study of allogeneic CAR-T UCART19, as well as preclinical data on a BCMA CAR-T for multiple myeloma.
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NICE recommends Kymriah to the Cancer Drugs Fund due to remaining questions about evidence to support it, but believes those questions will be resolved.
Along with Boston Scientific's Watchman in the technology category, Novartis and Gilead's Kite shared the biotechnology award for CAR-T therapy, while Celgene/Agios's Idhifa won the pharmaceutical prize.
A manufacturing error during a clinical trial of Kymriah, now marketed by Novartis, is less likely today, but could be an issue as CAR-Ts move into earlier therapy lines.
The deal will bring the CAR-T therapy to China's burgeoning market, but it faces competition from Gilead's Yescarta - manufactured under a JV with Fosun - and also homegrown products.
The clinical trial of the CAR-T - a potential competitor to bluebird bio's - will start enrolling patients later this year.