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.

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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.

The post Cell Therapy Now Set to Reach More Patients With Expanded FDA Nod for 2 Multiple Myeloma Drugs appeared first on MedCity News.

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.

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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.

The post GSK Drug Pulled From Market Beats J&J Multiple Myeloma Med in Phase 3 Test appeared first on MedCity News.

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.

The post Gilead’s $285M Confidence Vote for Next-Gen Cancer Med & New Cell Therapy Tech appeared first on MedCity News.

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.

The post Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug appeared first on MedCity News.

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.

The post J&J Broadens Scope in Multiple Myeloma, Winning FDA Approval for New Drug appeared first on MedCity News.

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.

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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.

The post ASCO Recap: Multiple Myeloma Moves, ADC Advances & Brain Cancer Progress appeared first on MedCity News.

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.

The post J&J Aims to Expand in Multiple Myeloma With First Drug for Novel Target appeared first on MedCity News.

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.

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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.

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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.

The post J&J, Legend win FDA nod for cell therapy challenger to BMS in multiple myeloma appeared first on MedCity News.

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 post AbbVie acquires TeneoOne to keep pace in chase for new multiple myeloma drugs appeared first on MedCity News.

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.

The post Bristol Myers Squibb wins first CAR-T therapy approval in multiple myeloma appeared first on MedCity News.

The companies said Tuesday that the FDA had accepted their application for idecabtagene vicleucel, which they resubmitted in July after the agency initially refused to file it in May. The action date is in March of next year.

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Blenrep, an antibody-drug conjugate, is the first drug approved for multiple myeloma that targets the antigen BCMA. Several other companies are also developing BCMA-targeting therapies for the blood cancer, including CAR-T cells and bispecific antibodies.

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The companies’ resubmission of their application Wednesday seeking approval for idecabtagene vicleucel was in line with the timeline they provided in May, when the FDA sent a refuse-to-file letter in response to their initial submission.

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The Oncologic Drugs Advisory Committee voted 12-0 that the benefit-risk profile of belantamab mafodotin supported the drug. The vote came despite concerns expressed by the FDA in briefing documents ahead of the ODAC meeting, particularly with regard to ocular toxicity.

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The FDA’s Oncologic Drugs Advisory Committee will convene Tuesday to discuss the drug, belantamab mafodotin. Despite the drug’s first-in-class potential, the briefing document for the meeting raised concerns about eye toxicity and questions about its risk-benefit profile.

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The patient, who had been enrolled in the Phase I study at the higher dose level of UCARTCS1A, suffered a cardiac arrest, the causes of which are under investigation, the company said.

The post FDA slaps hold on Cellectis’ off-the-shelf myeloma CAR-T trial after patient death appeared first on MedCity News.

The drug, belantamab mafodotin, could become the first approved therapy for multiple myeloma that targets the cell-surface antigen BCMA. The FDA accepted the application for the drug in January.

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Johnson & Johnson, which in-licensed Legend’s CAR-T technology and is developing a version of its product under the name JNJ-4528, presented data from the Phase Ib/II CARTITUDE-1 study at the ASCO meeting.

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Data for the drug, CC-92480, showed an overall response rate of more than 54% when given at the recommended Phase II dose in 11 heavily pretreated patients. The drug is part of a new class known as CELMoD agents.

The post BMS’ ‘CAR-T in a pill’ multiple myeloma drug has strong early showing at ASCO appeared first on MedCity News.

In a presentation of data at ASCO on the Phase I/II study of orvacabtagene autoleucel in patients with heavily pretreated multiple myeloma, it was stated that the study added a new cohort of patients with prior exposure to therapies that, like orva-cel, target the BCMA antigen.

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The company said the DREAMM-2 study of belantamab mafodotin, its antibody-drug conjugate that targets BCMA, showed a median overall survival of nealry 15 months in heavily pretreated patients.

The post GSK gives taste of data on multiple myeloma drug ahead of ASCO appeared first on MedCity News.

The company will present data from the Phase I trial of teclistamab in an oral session at the ASCO virtual meeting later this month. The drug, a bispecific monoclonal antibody against the antigen BCMA, is a potential competitor to a similar therapy developed by Amgen.

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Data on the CAR-T, JNJ-4528, will be presented at the ASCO virtual meeting. In an interview, a J&J executive talked about how the therapy could be developed for outpatient use through patient self-monitoring.

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The FDA requested supplemental documentation related to chemistry, manufacturing and controls rather than new clinical or preclinical data. The companies plan to resubmit the application and request a priority review by the end of July.

The post bluebird, BMS hit roadblock as FDA delivers refuse-to-file letter for myeloma CAR-T appeared first on MedCity News.