Bristol-Myers Squibb Company — Sprycel FDA Review (NDA/BLA 021986, 2026)
Bristol-Myers Squibb Company · 2026 · FDA Review (Drugs@FDA) · company profile →
Report summary
This FDA approval package details the supplemental new drug application for Bristol-Myers Squibb's SPRYCEL (dasatinib) for pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, approved November 9, 2017. The review, based on studies CA180018 and CA180226, recommends regular approval due to significant efficacy (high response rates including MCyR, CCyR, and MMR) and an acceptable safety profile, comparable to or better than adults. The report covers dasatinib's pharmacokinetics, including weight-tiered dosing for pediatric patients, and its safety profile, detailing adverse reactions and treatment discontinuation rates. Labeling recommendations for clarity and safety are also included.
Key findings — cited to the page
| Pleural effusion (Grade 3/4) | 3 % | newly diagnosed chronic phase CML · p.18 |
| Pleural effusion (All Grades) | 28 % | newly diagnosed chronic phase CML · p.18 |
| Grade 3 or 4 pleural effusion in advanced phase CML or Ph+ ALL adults | 7 % | SPRYCEL · p.14 |
| Grade 3 or 4 fluid retention in advanced phase CML or Ph+ ALL adults | 8 % | SPRYCEL · p.14 |
| Fluid retention (All Grades) | 38 % | newly diagnosed chronic phase CML · p.18 |
| Fluid retention (Grade 3/4) | 5 % | newly diagnosed chronic phase CML · p.18 |
| Grade 3 or 4 fluid retention in newly diagnosed chronic phase CML adults | 5 % | SPRYCEL · p.14 |
| Thrombocytopenia (Grade 3/4) | 63 % | Advanced Phase CML (140 mg Once Daily, Accelerated Phase) · p.25 |
| Grade 3 or 4 pleural effusion in newly diagnosed chronic phase CML adults | 3 % | SPRYCEL · p.14 |
| Grade 3 or 4 fluid retention in newly diagnosed or imatinib-resistant or -intolerant chronic phase CML adults | 6 % | SPRYCEL · p.14 |
| Grade 1 or 2 fluid retention in pediatric patients with chronic phase CML | 10.3 % | SPRYCEL · p.14 |
| Superficial localized edema (All Grades) | 14 % | newly diagnosed chronic phase CML · p.18 |
Source: Bristol-Myers Squibb Company ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →