Talvey Gets Accelerated Approval for Myeloma Treatment


The FDA granted an accelerated approval for Talvey to treat patients with relapsed/refractory multiple myeloma.

The Food and Drug Administration (FDA) granted an accelerated approval to Talvey (talquetamab-tgvs) for the treatment of adults with relapsed/refractory multiple myeloma who have received four or more prior treatments, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, according to Janssen, the manufacturer of the drug.

“Patients at this stage of disease have a poor prognosis. (Talvey) as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer,” said Dr. Ajai Chari, director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco, in a press release.

The accelerated approval is based on findings from the phase 2 MonumenTAL-1 trial, which included 187 pretreated patients with myeloma. Among patients who received an 0.8 mg/kg dose, the overall response rate (percentage of patients whose disease shrinks or disappears from treatment) was 73.6%. Additionally, with an average follow up of six months from the first response, 58% of patients achieved a very good partial response (shrinking of cancer), with 33% achieving a complete response (disappearance of cancer).

Among patients who received a lower dose (0.4mg/kg), 73% of patients responded. At a median follow up of about 14 months, 57% achieved a very good partial response or better, with 35% achieving a complete response.

The average duration of response was not reached in the higher dose, though it is estimated that 85% of responders maintained a response of nine or more month. The average duration of response was 9.5 months in the 0.4 mg/kg dose.

Continued approval of Talvey is dependent on further follow-up from the trial.

“The clinically meaningful efficacy and safety profile observed with (Talvey) in heavily pretreated patients in this clinical trial, which included patients treated with prior BCMA-targeted bispecific or CAR-T cell therapy, has been notable,” Chari said.

Talvey comes with a Boxed Warning, informing patients and providers about the possibility of cytoline release syndrome and neurologic toxicity, which can include immune effector cell-associated neurotoxicity syndrome (ICANS) — potentially dangerous conditions that can occur after a flood of immune cells called cytokines enter the blood stream. The drug also has warnings for mouth-related side effects, weight loss, infection, cytopenias, skin side effects, liver toxicity and embryo-fetal toxicity.

The most common side effects that happened in 20% or more of patients on the MonumenTAL-1 trial included: fever, cytokine release syndrome, bad taste in the mouth, nail toxicity, musculoskeleyal pain, skin toxicity, rash, fatigue, weight loss, dry mouth, xerosis (dry skin), dysphagia (difficulty swallowing), upper respiratory tract infection, diarrhea, low blood pressure and headache.

The most common grade 3 or 4 lab abnormalities that occurred in 30% or more of patients on the trial were decreases in lymphocytes, neurophils, white blood cells and hemoglobin.

“Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options," said Michael Andreini, president and chief executive officer, Multiple Myeloma Research Foundation. “Today's approval of (Talvey) provides patients with a new treatment approach for relapsed or refractory disease that is a welcome addition to the myeloma community.”

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