RECENT FDA APPROVALS

Drug Name Manufacturer

elacestrant (Orserdu™)

Stemline Therapeutics pirtobrutinib (Jaypirca™) Loxo Oncology

Description

New Drugs

• NDA approval 01/27/2023; Assessment Aid, Fast Track, Priority Review

• Indicated for treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following ≥ 1 line of endocrine therapy; select patients for treatment based on the presence of ESR1 mutations

• Estrogen receptor antagonist

• Oral tablet: 86 mg, 345 mg

• Recommended dosage is 345 mg once daily with food; dose modifications, including interruption of therapy, reduction, or permanent discontinuation, may be required depending on adverse event severity

• NDA approval 01/27/2023; Accelerated Approval, Orphan Drug, Priority Review

• Indicated for the treatment of adults with relapsed or refractory mantle cell lymphoma after ≥ 2 lines of systemic therapy, including a BTK inhibitor; continued approval for this use may require demonstration of benefit in confirmatory clinical trials

• Kinase inhibitor

• Oral tablet: 50 mg, 100 mg

• Recommended dosage is 200 mg once daily; dose modifications, including interruption of therapy, reduction, or permanent discontinuation, may be required depending on adverse event severity