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.
Gilead Sciences is increasing its stake in partner Arcellx and expanding the cell therapy alliance the companies started in 2022. The deal expands the lead partnered program to more cancers and gives Gilead a chance at another Arcellx cell therapy candidate made with different technology.
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.
AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the latest deal made by a big pharmaceutical company looking to get its hands on a new type of cancer therapy called a T cell engager.
For the second time in a week, the FDA placed a clinical hold on an Aprea Therapeutics cancer drug. The biotech said the agency cited safety and efficacy data from a prior failed clinical trial that tested the small molecule in a different form of cancer.
The findings may make it possible to identify a subset of patients who experience poorer outcomes or more serious side effects, especially neurotoxicity.
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.
While cautioning that it's still early days, experts said the data - especially those showing much lower toxicity - raise the prospect that the therapy could replace autologous CAR-Ts, if its efficacy remains the same.
Bristol-Myers Squibb said the FDA had accepted and granted priority review to its application for lisocabtagene maraleucel in diffuse large B-cell lymphoma. The agency will decide whether to approve it by Aug. 17. Two other CAR-Ts are already approved for DLBCL.
The biotech company's Kite Pharma subsidiary said the FDA had granted priority review for KTE-X19 in mantle cell lymphoma. The company already markets the CAR-T Yescarta for diffuse large B-cell lymphoma.
The deal, worth up to $2B in milestones and other other payments, involves the monoclonal antibody tafasitamab, for which MorphoSys recently submitted an FDA approval application.
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The German biotech company said Monday it had applied for approval of tafasitamab in diffuse large B-cell lymphoma, which targets the same antigen as CAR-T, but would be for a population unable to tolerate the cell therapies.
On the back of positive data presented at the recently concluded ASH meeting, Kite filed for approval of KTE-X19 in mantle cell lymphoma. The company currently markets another CAR-T, Yescarta, for a different form of lymphoma.
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.
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.