|Generic Name||Brand Name||Dosage Form||Company||Ticker||FDA Approved Indications||Approval|
|Alpelisib||Piqray||Oral Tablet||Novartis||NVS||Treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen in combination with fulvestrant.||Full|
|Copanlisib||Aliqopa||IV Infusion||Bayer||BAYN||Relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.||Accelerated|
|Duvelisib||Copiktra||Oral Capsule||Verastem||VSTM||Relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies.||Full|
|Duvelisib||Copiktra||Oral Capsule||Verastem||VSTM||Relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies.||Accelerated|
|Idelalisib||Zydelig||Oral Tablet||Gilead||GILD||Relapsed chronic lymphocytic leukemia (CLL), in combination with rituximab, in patients for whom rituximab alone would be considered appropriate therapy due to other co-morbidities.||Full|
|Idelalisib||Zydelig||Oral Tablet||Gilead||GILD||Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in patients who have received at least two prior systemic therapies.||Full|
|Idelalisib||Zydelig||Oral Tablet||Gilead||GILD||Relapsed small lymphocytic lymphoma (SLL) in patients who have received at least two prior 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.