Table 7.

Selected Drugs and Biologicals That Have Already or May Receive FDA-Approved Labeling in 2022^a

Drug or biological	Manufacturer	Indication	Route	Type of application	PDUFA date (month or quarter)b
Tebentafusp-tebn	Immunocore	Uveal melanoma	IV	BLA	Approved (Jan)
Sutimlimab-jome	Sanofi	Cold agglutinin disease	IV	BLA	Approved (Feb)
Mitapivat sulfate	Agios	Pyruvate kinase deficiency	Oral	NDA	Approved (Feb)
Ciltacabtagene autoleucel	Janssen	Relapsed or refractory multiple myeloma	IV	BLA	Approved (Feb)
Penpulimab	Akeso Biopharma	Nasopharyngeal carcinoma	IV	BLA	Q1
Nivolumab/relatlimab	Bristol-Myers Squibb	Unresectable or metastatic melanoma	IV	BLA	Q1
Ganaxolone	Marinus	Seizures associated with cyclin-dependent kinase-like 5 deficiency disorder	Oral, IV	NDA	Q1
Vadadustat	Akebia Therapeutics	Anemia due to chronic kidney disease	Oral	NDA	Q1
Tirzepatide	Eli Lilly	Type 2 diabetes	SC	NDA	Q2
Toripalimab	Coherus biosciences	Advanced recurrent or metastatic nasopharyngeal carcinoma	IV	BLA	Q2
Vutrisiran	Alnylam Pharmaceuticals	Polyneuropathy of hereditary transthyretin-mediated amyloidosis	SC	NDA	Q2
Mavacamten	Bristol-Myers Squibb	Hypertrophic cardiomyopathy	Oral	NDA	Q2
Spesolimab	Boehringer Ingelheim	Pustular psoriasis	IV	BLA	Q2
Tebipenem pivoxil hydrobromide	Spero therapeutics	Complicated UTI	Oral	NDA	Q2
Tauroursodeoxycholic acid and sodium phenylbutyrate	Amylyx Pharmaceuticals	Amyotrophic lateral sclerosis	Oral	NDA	Q2
Teclistamab	Janssen	Relapsed or refractory multiple myeloma	SC	BLA	Q3
Bulevirtide	Gilead	Hepatitis delta virus infection	SC	BLA	Q3
Poziotinib	Spectrum Pharmaceutical	Non–small cell lung cancer	Oral	NDA	Q3
Tislelizumab	Novartis	Unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma	IV	BLA	Q3
Betibeglogene autotemcel	Bluebird bio	Beta thalassemia	IV	BLA	Q3
Deucravacitinib	Bristol-Myers Squibb	Moderate to severe plaque psoriasis	Oral	NDA	Q3
Elivaldogene autotemcel	Bluebird bio	Cerebral adrenoleukodystrophy	IV	BLA	Q3

Abbreviations: FDA, Food and Drug Administration; PDUFA, Prescription Drug User Fee Act; IV, intravenous; BLA, biologic license application; Q, quarter; NDA, new drug application; SC, subcutaneous.

^aInformation for this table was extracted from the IPD Analytics Brand and Biosimilar Pipeline database (see extended Methods description in eSupplement).

^bExtrapolated on the basis of new drug application submission date and review status (ie, 10 months for standard review and 6 months for priority review). Some agents listed may have been approved by the time of publication.