Monday, September 25, 2023

Pfizer Expands to Multiple Myeloma With FDA Approval for New Antibody Drug – MedCity News

Pfizer’s portfolio of medicines is expanding to multiple myeloma with FDA approval of a new drug that will compete head to head with a Johnson & Johnson product that addresses the same cancer target.

The Pfizer drug, elranatamab, is approved for treating advanced cases of multiple myeloma that have progressed after at least four earlier lines of therapy. The regulatory decision is an accelerated approval that will require Pfizer to confirm patient benefit with post-marketing testing. The pharmaceutical giant will commercialize its new subcutaneously administered drug under the brand name Elrexfio.

Elrexfio is a bispecific antibody engineered to bind to two targets. On T cells, it binds to a protein called CD38. On tumors, it binds to BCMA, a protein abundant on the surface of multiple myeloma cells. Binding to both targets brings the T cell and cancer cell together, activating the immune cell to kill the cancer cell.

FDA approval is based on results from a Phase 2 study that showed an overall response rate of 58%. Of those who responded to treatment, an estimated 82% maintained that response for at least nine months.

The approved indication for Elrexfio mirrors that of Tecvayli, a BCMA-targeting bispecific antibody from J&J that won its regulatory nod in multiple myeloma last year. After step-up dosing, Tecvayli is administered once weekly. Pfizer’s new drug comes with the advantage of less frequent dosing. After step-up dosing, Elrexfio is administered every other week.

Elrexfio’s label carries a black box warning that alerts patients and physicians that the drug may cause excessive immune responses and neurotoxicity, known complications that are also flagged on the labels of other cancer immunotherapies. Pfizer has additional clinical trials underway evaluating Elrexfio in earlier lines of treatment, both as a monotherapy and in combination with other drugs.

We’re in the dog days of August but it has not been a slow time for regulatory news. Here’s a recap of recent regulatory developments:

—In other multiple myeloma drug news, the FDA awarded accelerated approved to J&J’s Talvey. The drug is a bispecific antibody like Tecvayli. But Talvey is the first drug approved to go after the cancer target GPRC5D. Talvey is J&J’s fifth approved multiple myeloma therapy.

J&J also received FDA approval for Akeega, a combination therapy for advanced cases of prostate cancer. One of the drug’s components is a PARP inhibitor that addresses cancers with a BRCA mutation. The FDA also approved a Foundation Medicine companion diagnostic that identifies patients whose cancer is eligible for this type of targeted cancer therapy.

—A Delcath Systems combination product is now FDA approved for treating metastatic uveal melanoma, a rare type of liver cancer. The product, called Hepzato Kit, uses a delivery system to administer hepzato, a well-established chemotherapy. This approach limits systemic toxicity while allowing for greater exposure of the drug to cancerous tissue. Hepzato Kit’s label includes a black box warning flagging risks that include bleeding and blood clot complications as well as liver injury from the procedure.

—The FDA lifted the partial clinical hold it placed on an experimental Arcellx cell therapy in June following a patient death. The therapy, CART-ddBCMA, is in pivotal testing as a treatment for advanced cases of multiple myeloma. At the time the hold was announced, the company said it believed a contributor to the death was the limitations of bridging therapy, the treatment that a patient receives while waiting for the personalized cell therapy to be manufactured. Arcellx said FDA is now allowing for expanded use of bridging therapies and the clinical trial protocol has been amended.

—Valneva’s bid to win FDA approval of the first chikungunya vaccine has been delayed by three months. The drug initially had an Aug. 19 target date for a regulatory decision. The France-based vaccine developer said the agency extended the review period to November to allow for enough time to iron out details of the post-marketing study required for accelerated approval.

—A 2SeventyBio cell therapy whose Phase 1 study was paused in June following a patient death is now under a formal FDA clinical hold. The cell therapy, SC-DARIC33, is in development as a potential treatment for acute myeloid leukemia. Cambridge, Massachusetts-based 2seventy said it continues to work with study collaborator Seattle Children’s Hospital to identify the cause of the complications and to amend the study protocol.

—Daxxify, a Revance Therapeutics product that won its first approval for improving the appearance of frown lines on the face, can now be used for a therapeutic indication. The FDA approved Daxxify for cervical dystonia, a disease that leads to involuntary contraction of neck muscles, leading to involuntary movements, pain, and awkward head and neck posture. Daxxify provides a treatment alternative to neuromodulators, a class of drugs currently used to treat the condition.

—Gavreto, a Roche drug that won accelerated approval in 2020 for treating non-small cell lung cancer, now has full FDA approval in that indication. But the regulatory decision comes at a time of transition for Gavreto, whose rights Roche had acquired from Blueprint Medicines. Sales have been disappointing, and Roche announced earlier this year that it is returning the drug’s rights to Blueprint. That transition is expected to conclude in February. Blueprint said it is exploring options to continue commercialization and development of Gavreto for cancers that have RET alterations.

—Novartis is withdrawing sickle cell disease drug Adakveo from the European market. The move comes after a European Medicines Agency committee recommended revoking the drug’s conditional marketing authorization after a Phase 3 study’s results failed to demonstrate a statistically significant difference compared to a placebo. Adakveo, which was developed to treat the sickle cell disease complication called vaso-occlusive crises, remains approved for use in the U.S. Novartis said it plans to discuss the Phase 3 results with the FDA and other regulatory bodies globally.

Sage Therapeutics received a mixed FDA decision for its depression drug, Zurzuvae. The agency approved the oral drug for treating postpartum depression but rejected it for major depressive disorder, a much larger indication. The outcome is also a disappointment for Biogen, which committed more than $1.5 billion to Sage in 2020, kicking off a development and commercialization alliance on the drug.

Photo: Dominick Reuter/AFP, via Getty Images

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