GSK drug Blenrep, which exited the market in 2022 after failing a confirmatory study, now has a new FDA approval as a third-line multiple myeloma treatment. The U.S. regulatory decision is more limited than the recent European approval for the blood cancer drug.
AbbVie has acquired rights to a multispecific antibody that IGI Therapeutics designed to bind to three targets to treat multiple myeloma. Early Phase 1 results showed encouraging responses in a heavily pretreated patient population and a favorable safety profile.
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Bispecific antibodies are already available for treating multiple myeloma. FDA approval of Regeneron Pharmaceuticals’ new drug, Lynozyfic, comes with dosing flexibility that sets it apart from others in its class.
Johnson & Johnson has projected its lung cancer drug Rybrevant could achieve $5 billion in peak revenue. At the recent ASCO annual meeting, J&J executive Joshua Bauml explained his company’s strategy for this drug in lung cancer and beyond.
AstraZeneca’s EsoBiotec acquisition is the latest in a series of deals struck by the pharma giant to secure a place in the next wave of cell therapies for cancer and immune-mediated diseases. EsoBiotec’s allogeneic cell therapies are made by the in vivo reprogramming of a patient’s immune cells.
Multiple myeloma cell therapy Abecma is the lone remaining asset of 2seventy Bio, which spun out from Bluebird Bio in 2021. 2seventy and Bristol Myers Squibb currently share in U.S. commercialization of Abecma.
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
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.
Arcellx’s cell therapy for multiple myeloma has shown no signs of the parkinsonism complication observed in clinical testing of Carvykti, a rival product from partners Johnson & Johnon and Legend Biotech. Arcellx is developing its CAR T-treatment under a partnership with Gilead Sciences.
Results from the Phase 3 DREAMM-7 study show GSK drug Blenrep is helping multiple myeloma patients live longer compared to treatment with blockbuster Johnson & Johnson drug Darzalex. The data, presented Monday during the annual meeting of the American Society of Hematology, are part of a submission now under FDA review that could lead to Blenrep’s return to the market.
Regeneron Pharmaceuticals said the FDA cited no approvability concerns for its multiple myeloma drug, linvoseltamab, other than previously identified issues with a contract manufacturer. While linvoseltamab trails bispecific antibodies currently marketed by Johnson & Johnson and Pfizer, if approved, it could bring patients an earlier treatment option.
Healthcare in the U.S. today exists in a complex, fragmented and costly system, and the people this system is designed for deserve a holistic approach to best address their individual health needs.
GSK’s Blenrep has pivotal clinical trial results showing the multiple myeloma therapy reduced the risk of disease progression or death by nearly 50%. The results were presented Sunday during the annual meeting of the America Society of Clinical Oncology.
The CAR T-therapies Abecma and Carvykti may now be used in earlier lines of treatment for multiple myeloma. The expanded FDA approvals makes these cell therapies more accessible to more patients, broadening the market for both products.
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.
GSK took Blenrep off the market last year after the multiple myeloma drug failed its confirmatory study. But GSK now says it has interim data showing Blenrep beat a blockbuster Johnson & Johnson drug in a head-to-head Phase 3 study testing it as an earlier line of therapy.
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.