|Generic Name||Brand Name||Dosage Form||Company||Ticker||FDA Approved Indications||Approval|
|Belinostat||Beleodaq||IV Infusion||Acrotech||Private||Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).||Accelerated|
|Panobinostat||Farydak||Oral Capsule||Secura Bio||Private||In combination with bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent.||Accelerated|
|Romidepsin||Istodax||IV Infusion||Bristol-Myers Squibb||BMY||Treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy.||Full|
|Romidepsin||Istodax||IV Infusion||Bristol-Myers Squibb||BMY||Treatment of peripheral T-cell lymphoma (PTCL) in adult patients who have received at least one prior therapy.||Accelerated|
|Vorinostat||Zolinza||Oral Capsule||Merck||MRK||Treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.||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.