Jaypirca

Treats relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of…. NDA 216059, held by Loxo Oncol. Pirtobrutinib.

As of Nov 14, 2026, NDA 216059 (Jaypirca), held by Loxo Oncol, was first approved by FDA on Jan 27, 2023, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2023
Review: Priority
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

JAYPIRCA is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Oct 2, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 1, 2023	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 27, 2023	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

2 strengths and forms


Jaypirca50MG · tablet;oral	Pirtobrutinib	RxReference drug
Jaypirca100MG · tablet;oral	Pirtobrutinib	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Oct 2, 2026	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 2, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 4, 2024	Supplement 2Labeling	Approved	Letter Label
Dec 1, 2023	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 27, 2023	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 216059
Drugs@FDA: Overview at FDA
Company: Loxo Oncology

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters