FDA Approves Reborn Multiple Myeloma Drugs and Drugs in J&J and Pfizer
Regeneron Pharmaceuticals is accelerating its cancer drug line through the FDA approval of bispecific antibodies it develops for multiple myeloma, the second common type of hematologic cancer.
Plasma cell carcinoma is common in multiple myeloma. When this occurs, the patient may need a different drug or combination of drugs than the ones received before, especially in a later treatment regimen. Regeneron Drug Linvoseltamab's Wednesday approval covers treatment for adults who have relapsed or have not responded to at least four early treatments. Regeneron will market its new products under the brand name Lynozyfic.
Lynozyfic comes from Velocimmune, a proprietary regeneration technology that generates fully human antibodies for target targets. The novel recovery bispecific antibody has been designed to target BCMA to CD3 of multiple myeloma cells and T cells. The binding with both activates T cells simultaneously to kill cancer cells.
According to the results of the Phase 1/2 test, Regeneron seeks FDA approval for Lynozyfic to be used after three to four multiple myeloma treatments. Earlier treatments are included in the current approval. The FDA said its decision was based on the efficacy of 80 patients receiving 40 treatments. In these patients, the results showed an objective response rate of 70%. Of the median follow-up of 11.3 months among these responders, the estimated response duration was 89% at 9 months and 72% at 12 months.
The limbs are administered as intravenous infusion and can be administered every two weeks after escalation of administration. If the patient shows very good or partial response to treatment, the dose schedule can be changed to every four weeks. This is the dosage advantage over other bispecific antibodies for multiple myeloma.
Tecvayli, a BCMA/CD3 targeted drug sold by Johnson and Johnson, was initially approved as a weekly managed drug. Last year, the FDA approved a two-week dose, making patients more flexible. J&J has another bispecific drug, Talvey, which targets GPRC5D of cancer cells and CD3 of T cells. TALVEY is taken once a week or two weeks after the dose is taken. Meanwhile, Pfizer's bispecific antibody for multiple myeloma is Elrexfio, which targets cancer cells' BCMA and T cells' CD38. Elrexfio is given every two weeks after upgrading the dose.
New Regeneron medicine is a meaningful advance in the treatment of multiple myeloma, an investigator in the Lynozyfic clinical trial, said the new Regeneron drug is a meaningful advance in the treatment of multiple myeloma.
“Lynozyfic has a convenient responsive adaptive dose regimen, which provides the potential to extend time between doses,” Janannath said in a Regeneron approval announcement. “This is a significant patient-centered advancement that can help reduce the burden of treatment.”
After approval in Europe in April, Lynozyfic has been available in Europe. The European Commission’s decision, which covers at least three previously treated patients, is a conditional marketing authorization requiring Regeneron to generate additional clinical data to verify patient benefits. Similarly, the FDA decision is to accelerate approval. A phase 3 test designed as a confirmatory study is underway. Although the FDA nodded as an accelerated approval, it was later than Regeneron hoped. Last August, the FDA rejected Lynozyfic's submission, citing issues with the drug's third-party manufacturer's issuance.
Lynozyfic’s tags issue a black box warning that the risk of excessive, called cytokine release syndrome and the risk of neurotoxicity. Labels for other cancer immunotherapy – including other bispecific antibodies for multiple myeloma – carry similar black box warnings. Because of these risks, the FDA requires Lynozyfic to be provided only through risk assessment and mitigation strategies, a safety program that provides information about these risks to prescribers and patients and provides a way to manage them.
Regeneron’s main cancer asset is the checkpoint inhibitor Libtayo, which has global sales of $1.2 billion in 2024. This antibody comes from Velocimmune and is the backbone of Regeneron's drug combination strategy in hematologic cancer and solid tumors. The pipeline includes OdRonextamab, also from Velocimmune. The bispecific antibody is currently being reviewed by the FDA as a potential treatment for relapsed or refractory follicle lymphoma. The FDA decision is expected to be made by July 30.
Photo: Michael Nagle/Bloomberg, by Getty Images
