FDA approval tracker: March

 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	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. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-march-0