US FDA approval tracker: March

Snippets

Fibrogen and Astrazeneca had been gearing up for an approval decision on their chronic kidney disease project roxadustat last month, but a surprise advisory panel meeting is now in the works, at a date yet to be determined. Experts will play close attention to cardiac safety issues with the oral HIF-PH inhibitor. Akebia, which recently filed vadadustat, a similarly acting project with its own toxicity problems, will be watching the adcom with interest. Elsewhere, Keytruda got knocked back in neoadjuvant/adjuvant triple-negative breast cancer after a negative vote from an earlier panel meeting. Merck & Co will likely have to wait for data on event-free survival from the Keynote-522 study to get another shot here; these are due in the third quarter. Merck also voluntarily withdrew Keytruda's use in small-cell lung cancer. The anti-PD-1 antibody, alongside Roche's Tecentriq and Bristol's Opdivo, will be the subject of a panel towards the end of April looking at accelerated approvals for six indications in which confirmatory studies have failed (Go or no go? The FDA plays hardball, March 30, 2021).

Notable first-time US approval decisions in March
Project Company 2026e sales by indication ($m) Outcome
Evrenzo (roxadustat) Astrazeneca/Fibrogen/
Astellas
2,656 Adcom planned, no date disclosed
Abecma (ide-cel) Bristol Myers Squibb/
Bluebird
1,198 Approved
Mirabegron oral suspension Astellas 579* Approved
Dostarlimab Glaxosmithkline 537 No decision yet
DaxibotulinumtoxinA Revance 356 No decision yet
Rolontis Spectrum 344 Pre-approval inspection scheduled for May
Zegalogue (Dasiglucagon HypoPal Rescue Pen) Zealand Pharma 268 Approved
Fotivda Aveo 155 Approved (~3 weeks early)
Trevyent United Therapeutics 41 Company discontinued development after receiving FDA comments; CRL in Apr 2020
Azstarys (KP145) Kempharm/
Aquestive
- Approved
Ponvory (ponesimod) J&J/Idorsia - Approved
Besremi (ropeginterferon alfa-2b) AOP/PharmaEssentia - CRL (manufacturing inspection delay)
*Includes sales for tablet version (Myrbetriq). Source: EvaluatePharma & company releases.

 

Advisory committee meetings in March
Project Company  2026e sales by indication ($m) Note
Tanezumab Lilly/Pfizer 179 Negative, Pdufa estimated in Apr
Source: EvaluatePharma & FDA adcom calendar.

 

Supplementary and other notable approval decisions in March
Product Company Indication (clinical trial) Outcome
Sarclisa Sanofi R/r multiple myeloma, combo with Kyprolis & dexamethasone (Ikema) Approved (~3mth early)
Yescarta Gilead R/r follicular lymphoma & marginal zone lymphoma after ≥2 systemics (Zuma-5) Approved
Arcalyst
(rilonacept)
Kiniksa Recurrent pericarditis (Rhapsody) Approved 
Exparel Pacira Postsurgical analgesia in children aged ≥6 (Play) Approved 
Myrbetriq
(mirabegron tablets)
Astellas Neurogenic detrusor overactivity in patients aged ≥3 (NCT02751931) Approved
Keytruda Merck & Co TNBC in combo with chemo as neoadjuvant, also single agent as adjuvant (Keynote-522) CRL (negative adcom in Feb)
Keytruda Merck & Co 1L oesophageal/gastroesophageal junction carcinoma (Keynote-590) Approved 
Xolair Roche/Novartis Self-administration option across all approved US indications No decision yet
Vazalore Plx Pharma Liquid-filled aspirin capsule (325mg and 81mg doses) Approved
Lorbrena Pfizer 1L Alk +ve NSCLC (Crown) Approved
Kimyrsa/
Orbactiv
Melinta Acute bacterial skin and skin structure infections, single one-hour infusion  Approved
Source: EvaluatePharma & company releases.
 
Voluntarily withdrawn accelerated approvals in March
Product Company Setting (failed confirmatory study)
Keytruda Merck & Co 3L SCLC (Keynote-604)
Tecentriq Roche 1L urothelial bladder cancer (Imvigor-211)
Source: company releases.

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