|Generic Name||Brand Name||Dosage Form||Company||Ticker||FDA Approved Indications||Approval
|Glasdegib||Daurismo||Oral Tablets||Pfizer||PFE||In combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.||Full|
|Sonidegib||Odomzo||Oral Capsules||Sun Pharma||Treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.||Full|
|Vismodegib||Erivedge||Oral Capsules||Genentech (Roche)||RHHBY||Treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation||Full|
The FDA’s Accelerated Approval program aims to promote earlier approval of drugs to fill an unmet medical need. As such, approval is based on a surrogate endpoint (laboratory measurement, tumor shrinkage, physical sign) that is thought to predict a clinical benefit. Use of surrogate endpoint(s) results in a shorter time in development prior to FDA approval.
If a company receives accelerated approval, they are still required to conduct an additional study to confirm the assumed clinical benefit. If the confirmatory trial shows a clinical benefit, then the FDA will grant traditional (“full”) approval. If the confirmatory trial does not show a clinical benefit, the FDA may elect to remove the drug from the market.