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.
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.
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.
Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.
Johnson & Johnson’s stable of multiple myeloma drugs has grown to five products with the FDA approval of Talvey. The bispecific antibody is the first in a new class of new drugs designed to go after the novel multiple myeloma target GPRC5D.
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.
Arcellx attributes the death to limitations of the treatments that patients receive while their cell therapies are being manufactured. The company is working to expand these so-called bridging therapy options for patients.
During the annual meeting of the American Society of Clinical Oncology, a cell therapy posted clinical data that could broaden its use in multiple myeloma. In other developments, the class of drugs called ADCs continue to make progress and a novel brain cancer drug has Phase 3 data that support its use as a new treatment option.
Johnson & Johnson is seeking FDA approval of a multiple myeloma drug that could become the first one addressing a novel target called GPRC5D. Data from the Phase 1/2 study supporting the biologics license application were presented in New Orleans during the annual meeting of the American Society of Hematology.
Thermo Fisher Scientific’s acquisition of The Binding Site brings a company that specializes in diagnostic tests for blood cancers and immune system disorders. It’s Thermo Fisher’s biggest acquisition since its 2021 buyout of contract research organization PPD.
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FDA approval of Tecvayli, from Johnson & Johnson subsidiary Janssen Biotech, makes it the newest therapy that treats multiple myeloma by targeting the cancer protein BCMA. Though this off-the-shelf drug offers patients a more convenient dosing option, it comes with similar complication risks as other biologics approved for this type of blood cancer.
Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused on inflammatory bowel disease.
Approval of the Johnson & Johnson and Legend Biotech cell therapy, Carvykti, marks the second CAR T-cell therapy to clear the regulatory bar for multiple myeloma. The FDA approved Bristol Myers Squibb's cell therapy Abecma last year.
AbbVie is acquiring a Teneobio subsidiary developing a drug that targets BCMA, a popular protein target for multiple myeloma drugs. There are two FDA-approved BCMA-targeting therapies and more on the way, but AbbVie believes the newest addition to its pipeline could offer some advantages.
The FDA has approved a Bristol Myers Squibb cell therapy made by engineering a patient’s immune cells to target a cancer protein called BCMA. The regulatory decision for Abecma in multiple myeloma gives BMS its second approved CAR-T therapy.