Jylamvo

Treats acute lymphoblastic leukemia (ALL). NDA 212479, held by Shorla. Methotrexate.

As of Nov 14, 2026, NDA 212479 (Jylamvo), held by Shorla, was first approved by FDA on Nov 29, 2022, with 3 approved supplements and 1 published complete response letter.

First approved: Nov 29, 2022
Review: Standard
Supplements approved: 3
Complete response letters: 1

What It's For

From the FDA-approved label (Indications and Usage)

JYLAMVO is a folate analog metabolic inhibitor indicated for the: Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen Treatment of adults with mycosis fungoides Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen Treatment of adults with rheumatoid arthritis Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) Treatment of adults with severe psoriasis 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Oct 23, 2024	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 23, 2024	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter

Letter	Product	Now
Dec 22, 2021	Jylamvo (methotrexate)Product Quality	Approved

Products

4 strengths and forms


Jylamvo2MG/ML · solution;oral	Methotrexate	RxReference drug
Jylamvo2MG/ML · solution;oral	Methotrexate	Rx
Jylamvo2MG/ML · solution;oral	Methotrexate	Rx
Jylamvo2MG/ML · solution;oral	Methotrexate	Rx

All 7 submissions, including labeling and manufacturing supplements


May 27, 2026	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 23, 2024	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 23, 2024	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationEfficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 29, 2022	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 212479
Drugs@FDA: Overview at FDA
Company: SHORLA 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