Phyrago

Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. NDA 216099, held by Handa Therap. Dasatinib.

As of Nov 13, 2026, NDA 216099 (Phyrago), held by Handa Therap, was first approved by FDA on Dec 5, 2023, with 4 approved supplements and 0 published complete response letters.

First approved: Dec 5, 2023
Review: Standard
Supplements approved: 4
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Aug 1, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 5, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

6 strengths and forms

Product	Active ingredient	Marketing
Phyrago20MG · tablet;oral	Dasatinib	RxReference drug
Phyrago50MG · tablet;oral	Dasatinib	RxReference drug
Phyrago70MG · tablet;oral	Dasatinib	RxReference drug
Phyrago80MG · tablet;oral	Dasatinib	RxReference drug
Phyrago100MG · tablet;oral	Dasatinib	RxReference drug
Phyrago140MG · tablet;oral	Dasatinib	RxReference drug

All 5 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 16, 2026	Supplement 6Labeling · Standard review	Approved	Letter Label
Aug 1, 2025	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Dec 3, 2024	Supplement 3Labeling · Standard review	Approved	Label Letter
Jul 31, 2024	Supplement 4Labeling · Standard review	Approved	Letter Label
Dec 5, 2023	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 216099
Drugs@FDA: Overview at FDA
Company: Handa Therapeutics

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