FDA quickly approves J&J’s Darzalex in multiple myeloma

Johnson & Johnson’s Darzalex has acquired another indication after the FDA quickly approved it as part of a combination in newly-diagnosed multiple myeloma patients who are transplant ineligible.

J&J’s Janssen unit said the big-selling drug has been approved in combination with Celgene’s Revlimid (lenalidomide) and dexamethasone (Rd) for newly diagnosed patients who are ineligible for autologous stem cell transplant.

Approval is based on results from the phase 3 MAIA (MMY3008) clinical study, which showed that the combination significantly reduced the risk of disease progression or death by 44% compared to treatment with Rd alone.

The approval is one of the first via the FDA’s Real-Time Oncology Review (RTOR) pilot programme, which aims to expedite reviews to ensure cancer drugs are safe and effective, while also improving the quality of the reviews.

Janssen filed the drug in this indication in March, meaning the FDA has turned this approval around in just over three months.

The FDA’s Priority Reviews for promising new treatments usually last six months, while standard reviews can last as long as 10 months.

The FDA considers drugs for the RTOR programme if they look likely to be significantly better than approved therapies, have straight forward study designs, and have endpoints that are easily interpreted.

In this case the FDA approved on the basis of the phase 3 MAIA study, which showed that at a median 28-month follow-up period, Darzalex in combination with Rd significantly reduced the risk of disease progression or death by 44% in this patient group, compared to treatment with Rd alone.

Darzalex is a blockbuster in multiple myeloma with sales of $629 million in the first quarter of this year, up 45.5% on last year’s Q1.

Median progression-free survival in the Darzalex-Rd group has not yet been reached, compared with 31.9 months in those receiving Rd alone.

Craig Tendler, Janssen’s vice president of clinical development and global medical affairs for oncology, said: “Importantly, this milestone also highlights the efficiency of the FDA’s Real-Time Oncology Review process, ensuring that proven treatment regimens, such as Darzalex plus lenalidomide and dexamethasone, are made available to patients as soon as possible.”

Earlier this month Janssen signed a licence and option deal with Denmark’s Genmab, which co-developed Darzalex, to produce a successor in multiple myeloma, codenamed HexaBody-CD38.

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