|Generic Name||Brand Name||Dosage Form||Company||Ticker||FDA Approved Indications||Approval|
|Bortezomib||Velcade||IV Infusion||Takeda||TAK||Treatment of adult patients with multiple myeloma.||Full|
|Bortezomib||Velcade||IV Infusion||Takeda||TAK||Treatment of adult patients with mantle cell lymphoma.||Full|
|Carfilzomib||Kyprolis||IV Infusion||Amgen||AMGN||In combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy.||Full|
|Carfilzomib||Kyprolis||IV Infusion||Amgen||AMGN||Single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.||Full|
|Ixazomib||Ninlaro||Oral Capsule||Takeda||TAK||In combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.||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.