Table 2.

Drug approvals with expedited review in 2022

		Breakthrough	Fast Track	Orphan	Rare disease	Accelerated Approval
Amvuttra (vutrisiran)	Hereditary transthyretin (hATTR) amyloidosis with polyneuropathy		■	■	■
Camzyos (mavacamten)	Hypertrophic cardiomyopathy	■		■
Carvykti (ciltacabtagene autoleucel)	Multiple myeloma	■		■	■
Cibinqo (abrocitinib)	Atopic dermatitis (eczema)	■
Elahere (mirvetuximab soravtansine-gynx)	Ovarian cancer		■	■	■	■
Enjaymo (sutimlimab-jome)	Autoimmune hemolytic anemia	■		■	■
Hemgenix (etranacogene dezaparvovec-drlb)	Hemophilia B	■		■	■
Imjudo (tremelimumab-actl)	Hepatocellular cancer (including secondary metastases)			■	■
Kimmtrak (tebentafusp-tebn)	Uveal melanoma	■	■	■
Krazati (adagrasib)	Multiple myeloma					■
Lunsumio (mosunetuzumab-axgb)	Follicular lymphoma	■				■
Lytgobi (futibatinib)	Biliary tract cancer	■		■	■	■
Pluvicto (lutetium (177Lu) vipivotide tetraxetan)	Prostate cancer	■
Pyrukynd (mitapivat)	Pyruvate kinase deficiency		■	■	■
Rebyota (fecal microbiota, live-jslm)	C. difficile-associated diarrhea	■	■	■
Rezlidhia (olutasidenib)	Acute myeloid leukemia			■	■
Sezaby (phenobarbital sodium)	Seizure disorders			■
Skysona (elivaldogene autotemcel)	Adrenoleukodystrophy	■		■	■	■
Spevigo (spesolimab-sbzo)	Psoriasis	■		■
Sunlenca (lenacapavir)	HIV/AIDS	■	■
Takecab/Voquezna (vonoprazan fumarate)	Helicobacter pylori infection		■
Tecvayli (teclistamab-cqyv)	Multiple myeloma	■		■	■	■
Terlivaz (terlipressin)	Hepatorenal syndrome		■	■	■
Tzield (teplizumab-mzwv)	Type 1 diabetes mellitus	■		■
Vivjoa (oteseconazole)	Non-systemic fungal infections		■
Vonjo (pacritinib)	Myelofibrosis		■	■	■	■
Xenpozyme (olipudase alfa)	Niemann–Pick disease	■		■	■
Ztalmy (ganaxolone)	Seizure disorders			■	■
Zynteglo (betibeglogene autotemcel)	β-thalassemia	■	■	■	■