FDA red and green lights: December 2024

As 2024 came to a close Bristol Myers Squibb's subcutaneous nivolumab formulation, now trademarked Opdivo Qvantig, secured US approval for all adult solid tumour indications in which the IV form is greenlit. This marked a relatively busy month for the FDA, which gave its blessing to eight oncology drugs, five of which were approved for the first time.

The month also saw another subcutaneous formulation, that of Johnson & Johnson's Rybrevant, set back with a complete response letter, while a Tevimbra application still remains outstanding, and a datopotamab deruxtecan filing with a December PDUFA date was withdrawn earlier. Over the whole of 2024 ApexOnco counts 63 US approvals for significant oncology drugs, and six CRLs.

One of the CRL recipients, Astellas's Vyloy, did end up being approved in October, while December's approval for Checkpoint's Unloxcyt also marked a comeback from that drug's CRL, issued in December 2023. More significant problems remain for Regeneron, whose T-cell engager effort was knocked with two 2024 CRLs, covering odronextamab and linvoseltamab.

Halozyme's double win

For Opdivo Qvantig approval came two months earlier that an initial timeframe had suggested, after Bristol appealed against the 28 February 2025 PDUFA date initially set by the FDA.

The drug therefore became the second SC formulation of an anti-PD-(L)1 MAb to secure US approval; Roche's atezolizumab got the nod as Tecentriq Hybreza in September, after a one-year manufacturing-related delay. Both drugs use hyaluronidase technology licensed from Halozyme, which thus stands to be a significant beneficiary.

However, whether SC forms can eat into sales of Keytruda even after this IV drug loses patent protection, or whether they will simply shore up the IV versions of the Roche and Bristol products, remains to be seen. Not only is Keytruda heavily entrenched, Merck & Co is developing its own SC formulation, based on Alteogen's hyaluronidase tech, and it might already be in discussions with the FDA.

In December 2024 Checkpoint's Unloxcyt became the 11th PD-(L)1 drug to secure US approval, while BeiGene's Tevimbra, the 10th, added first-line PD-L1-positive gastric/gastroesophageal junction adenocarcinoma to its first approval, in second-line oesophageal squamous cell carcinoma in March. Still outstanding is an FDA decision on front-line oesophageal squamous cell carcinoma, initially expected last July.

First approvals

December US approvals also included first nods for Merus's Bizengri, an anti-HER2 x HER3 bispecific MAb, and Xcovery/Betta's Ensacove, an ALK inhibitor.

Mesoblast's Ryoncil was greenlit at the third time of asking, and Pfizer's Braftovi continued its rollercoaster journey. The latter molecule had been originated by Novartis, and sold for a negligible amount to Array, which itself was taken over by Pfizer.

As the new year gets under way a key FDA decision looms for Daiichi Sankyo/AstraZeneca's datopotamab deruxtecan, in HER2-negative breast cancer. The good news is that this indication has already been endorsed by Japan's regulator, which approved the drug as Datroway in December, but a more important setting, second-line NSCLC, has been abandoned in favour of EGFR-mutated disease.

Selected November 2024 US regulatory decisions in oncology

Note: PDAC=pancreatic ductal adenocarcinoma. Source: OncologyPipeline.