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USFDA green lights Janssen’s Talvey to treat multiple myeloma

The USFDA has granted accelerated approval to Janssen Pharmaceutical Companies for its cancer antibody treatment, Talvey, to treat multiple myeloma.

HQ Team

August 11, 2023: The USFDA has granted accelerated approval to Janssen Pharmaceutical Companies for its cancer antibody treatment, Talvey, to treat multiple myeloma.

The talquetamab injection was approved as a weekly or biweekly subcutaneous injection after an initial step-up phase, offering physicians the flexibility to determine the optimal treatment regimen for patients, according to a statement from Belgium-based Janssen, wholly owned by Johnson & Johnson.

The treatment is meant for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.

In multiple myeloma, these plasma cells change, spread rapidly and replace normal cells in the bone marrow with tumors. Multiple myeloma is the third most common blood cancer.

12,000 lives to be lost

In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the US and more than 12,000 people will die from the disease.

People living with multiple myeloma have a five-year relative survival rate of 59.8%.

While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels, and kidney problems or infections.

The talquetamab phase 2 clinical study, which included patients who had received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy, showed meaningful overall response rates or ORR.

At the subcutaneous biweekly dose of 0.8 mg/kg, 73.6% of patients achieved an ORR after an independent review assessment, according to the company statement.

New options

“The clinically meaningful efficacy and safety profile observed with talquetamab 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,” said Ajai Chari, M.D., Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco.*

“Patients at this stage of the disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer,” Mr Chari who was a paid consultant with Janssen said.

Due to the risk of immune effector cell-associated neurotoxins syndrome and serious and life-threatening or fatal reactions, Talvey is available only through a restricted program.

Physicians were advised to step up dosing to reduce the risk of cytokine release syndrome occurring because of Talvey injection or withhold treatment until the syndrome resolves and discontinue it based on severity.

Combination studies

“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 talquetamab provides patients with a new treatment approach for relapsed or refractory disease that is a welcome addition to the myeloma community.”

TALVEY™ is currently being investigated in combination and in sequence across all lines of multiple myeloma in studies with other bispecific antibodies as well as with existing standards of care.

In addition to the phase 1-2 clinical study of Tavely, it is also being evaluated in combination studies.

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