Despite a positive panel meeting Mesoblast’s paediatric graft-versus-host disease treatment Ryoncil still received a knockback from the US FDA, featuring as one of three rejections last month. Still, those concerned that the FDA is tightening up will have been relieved that Gavreto received an early green light in Ret fusion-positive NSCLC. Lilly’s Retevmo is already approved in the setting, but comes with a warning about QT prolongation, something Gavreto’s label does not include. Roche will co-commercialise Gavreto with Blueprint in the US after paying $650m up front for rights. Elsewhere, Glaxosnithkline's Nucala became the first biological approved in the US for hypereosinophilic syndrome, some way ahead of Astrazeneca’s Fasenra, which recently started a pivotal study in this setting. Glaxo is still due a decision on dostarlimab, a latecomer to the anti-PD-1 class, in recurrent endometrial cancer; a decision is expected before the year end.
| Notable first-time US approval decisions in September | |||
|---|---|---|---|
| Project | Company | Sales by indication ($m) | Outcome |
| Dostarlimab | Glaxosmithkline | 523 | No decision yet |
| Onureg (CC-486) | Bristol Myers Squibb | 466 | Approved |
| Ryoncil (remestemcel-L) | Mesoblast | 341 | CRL |
| Alkindi Sprinkle | Eton | 266 | Approved |
| Libervant | Aquestive | 197 | CRL |
| Lucassin/terlipressin | Mallinckrodt | 154 | CRL |
| Gavreto (pralsetinib) | Roche/Blueprint | 109* | Approved (~2 mths early) |
| Alaway Preservative Free ophthalmic solution (EM-100) | Eton/Bausch | - | Approved |
| *Forecast doesn’t include Roche numbers. Sources: company releases & EvaluatePharma. | |||
| Supplementary and other notable approval decisions in September | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Fetroja/Cefiderocol | Shionogi | Hospital-acquired bacterial pneumonia & ventilator-associated bacterial pneumonia (APEKS-NP) | Approved |
| Trelegy Ellipta | Glaxosmithkline | Asthma (Captain) | Approved |
| Trulicity | Lilly | 3mg and 4.5mg doses for type 2 diabetes (Award-11) | Approved |
| Nucala | Glaxosmithkline | Hypereosinophilic syndrome (NCT02836496) | Approved |
| Kalydeco | Vertex | Cystic fibrosis patients aged 4-6 months (Arrival) | Approved |
| Xeljanz | Pfizer | Children & adolescents with active polyarticular course juvenile idiopathic arthritis (NCT02592434) | Approved |
| Xolair | Novartis | Nasal polyps (Polyp 1 and 2) | No decision yet |
Sources: Sources: company releases & EvaluatePharma. | |||
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