The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial analysts say the changes should improve patient access to these personalized cancer treatments.
A multiple myeloma cell therapy has encouraging results analysts say could make it best in its class and a gene-editing therapy is showing early promise in sickle cell disease. Here’s a recap of those developments and others from the annual meeting of the American Society of Clinical Oncology.
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Kura Oncology already had a broad development plan for ziftomenib in leukemias, but the agreement with Kyowa Kirin provides the cash to execute it and a partner to commercialize the drug globally. Ziftomenib is in the same class of medicines as Syndax Pharmaceuticals’ Revuforj, which won FDA approval last week.
Approval of Syndax’s Revuforj for acute leukemia makes the twice-daily pill the first in a new class of drugs that block a cancer-driving protein called menin. Other companies developing menin inhibitors include Kura Oncology, Biomea Fusion, and Johnson & Johnson subsidiary Janssen.
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.
At a time when AI is reshaping pharma, Reverba Global CEO Cheryl Lubbert explained in an interview why empathy, context, and ethics still require a human touch.
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.
A new report by Paubox calls for healthcare IT leaders to dispose of outdated assumptions about email security and address the challenges of evolving cybersecurity threats.
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.
NICE recommends Kymriah to the Cancer Drugs Fund due to remaining questions about evidence to support it, but believes those questions will be resolved.