FDA green and red lights: July 2024
Darzalex added another string to its bow, while Kisqali’s early use has been delayed.
Darzalex added another string to its bow, while Kisqali’s early use has been delayed.
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
PDUFA date | Outcome | Drug | Company | Indication | Note |
---|---|---|---|---|---|
Assumed Jul 2024 | Full approval, 30 July | Darzalex Faspro | J&J/Genmab | 1st-line, ASCT-eligible multiple myeloma + Velcade, Revlimid and dexamethasone (additional use, Perseus) | Submitted Jan 2024 |
Assumed Jun 2024 | PDUFA delayed by 3 months | Kisqali | Novartis | Adjuvant breast cancer (additional use, Natalee) | Decision now expected in Q3 2024 |
Assumed Jun 2024 | Adcom 25 July, decision pending | Imfinzi | AstraZeneca | Neoadjuvant NSCLC (additional use, Aegean) | No vote at adcom |
Jul 2024 | Decision pending | Tevimbra | BeiGene | 1st-line oesophageal squamous cell carcinoma (additional use, Rationale-306) | BeiGene said in May 2024 that decision might be deferred owing to delay in site inspections |
Source: company statements.
745