FDA green and red lights: July 2024

July saw just one US oncology approval: yet another use for Johnson & Johnson and Genmab’s Darzalex. The subcutaneous version of the drug, branded Darzalex Faspro, has been given the go-ahead for first-line, transplant-eligible multiple myeloma patients as part of a new combo, based on the Perseus trial.

More excitement might be expected over afami-cel, which has become Adaptimmune's first approved therapy, but whose nod came on 1 August. The other big regulatory news of July was a delay for Novartis’s Kisqali in adjuvant breast cancer. A decision had been expected in June, based on the Natalee study, but the company said during its second-quarter earnings that the PDUFA date had been pushed back by three months. 

Novartis blamed manufacturing adjustments following FDA guidance on nitrosamine limits; approval is now expected by the end of the third quarter.

AstraZeneca will also have to wait a little longer for an extension of its anti-PD-L1 MAb Imfinzi into early NSCLC, but things could be worse. A July adcom to discuss the Aegean trial ended up being more benign than briefing documents had suggested, leaving a green light looking likely. However, there are still questions over whether this will cover full perioperative use, or merely the neoadjuvant setting. A verdict had been expected by June.

For Adaptimmune the approval of afami-cel, trademarked Tecelra, came three days before its PDUFA date. The engineered T-cell receptor therapy is greenlit for the niche of pretreated synovial sarcoma patients who are HLA-A*02 and MAGE-A4 positive, and the fact Adaptimmune's stock fell 8% on the news suggests that investors don't see a solo launch putting the group on its way to profitability any time soon. 

Darzalex expands again

Darzalex is already approved in various combinations for front-line multiple myeloma: Perseus tested the anti-CD38 MAb plus Velcade, Revlimid and dexamethasone, versus a Velcade, Revlimid and dexamethasone triplet. Results were presented at last year’s ASH meeting; the approval covers induction and consolidation therapy with the new regimen.

Darzalex is by far the biggest CD38-targeting drug, but Sanofi’s Sarclisa got a boost last year with positive results from the Imroz trial, in first-line transplant-ineligible multiple myeloma. Sarclisa has a PDUFA date here of 27 September. However, Sanofi has yet to get a subcutaneous version of Sarclisa to market.

And Darzalex might not be too far behind in the transplant-ineligible setting. J&J slipped into its second-quarter earnings call that its analogous Cepheus trial had met its primary endpoint, and that data would be presented at an upcoming medical meeting.

J&J also said the Aquila study, of Darzalex in high-risk smouldering multiple myeloma, had succeeded. Darzalex sold $9.8bn in 2023, while Sarclisa brought in €381m.

Selected July 2024 US regulatory decisions in oncology

Source: company statements.