FDA Grants Dasatinib Priority Review for Resistant CML

News
Article
Oncology NEWS InternationalOncology NEWS International Vol 15 No 4
Volume 15
Issue 4

The FDA has granted priority review to dasatinib (BMS-354825), developed by Bristol-Myers Squibb, for treatment of imatinib (Gleevec)-resistant or refractory chronic myelogenous leukemia (CML) in adults.

PRINCETON, New Jersey—The FDA has granted priority review to dasatinib (BMS-354825), developed by Bristol-Myers Squibb, for treatment of imatinib (Gleevec)-resistant or refractory chronic myelogenous leukemia (CML) in adults. Dasatinib, an oral, small-molecule tyrosine kinase inhibitor, exhibits greater potency than imatinib and inhibits the majority of kinase mutations resistant to imatinib. The new drug application also seeks approval of dasatinib for treatment of Philadelphia chromosome-positive adult acute lymphoblastic leukemia.

Articles in this issue
Phase II Trial of Velcade/Alimta Initiated in Advanced NSCLC
ONS Annual Congress Heralds Start of Oncology Nursing Month
All-Star Panel Spells Out Onc Promises, Problems
Surveillance for Colon, Breast Ca Falls Off 5 Years After Diagnosis
ODAC Says No to Gemzar for Ovarian Ca
Experts See Oncology Reimbursements Headed Down, Hard Negotiations With Payers Lie Ahead
Femara Effective Even After Years of No Therapy
XMRV Retrovirus Found in Some Prostate Ca's
Taxotere Wins FDA Approval for Advanced Gastric Cancer
Community Oncology Practices Struggle to Cope With the Extra Requirements of Medicare Part D
Director of NCI Nominated as New FDA Commissioner
TAM-01 Finds Longer Tamoxifen Duration Is Not Better
Erbitux Wins Approval for Squamous Cell H&N Cancer
Young Doctors Are Hungry for Psychological Oncology Training
Posaconazole Reduces Serious IFIs in High-Risk Patients
Recent Videos
Certain bridging therapies and abundant steroid use may complicate the T-cell collection process during CAR T therapy.
Educating community practices on CAR T referral and sequencing treatment strategies may help increase CAR T utilization.
Harmonizing protocols across the health care system may bolster the feasibility of giving bispecifics to those with lymphoma in a community setting.
Establishment of an AYA Lymphoma Consortium has facilitated a process to better understand and address gaps in knowledge for this patient group.
Adult and pediatric oncology collaboration in assessing nivolumab in advanced Hodgkin lymphoma facilitated the phase 3 SWOG S1826 findings.
Treatment paradigms differ between adult and pediatric oncologists when treating young adults with lymphoma.
No evidence indicates synergistic toxicity when combining radiation with CAR T-cell therapy in this population, according to Timothy Robinson, MD, PhD.
The addition of radiotherapy to CAR T-cell therapy may particularly benefit patients with localized disease, according to Timothy Robinson, MD, PhD.
Timothy Robinson, MD, PhD, discusses how radiation may play a role as bridging therapy to CAR T-cell therapy for patients with relapsed/refractory DLBCL.
A panel of 3 experts on CML
Related Content
The updated labeling also includes new information on the recommended dosage of fludarabine phosphate when given with cyclophosphamide and rituximab.

FDA Updates Fludarabine Phosphate Labeling in Chronic Lymphocytic Leukemia

Russ Conroy
November 21st 2024
Article

The updated labeling also includes new information on the recommended dosage of fludarabine phosphate when given with cyclophosphamide and rituximab.

A leader from the adolescent and young adult lymphoma space discusses how collaboration between adult and pediatric oncologists has transformed the field.

Collaboration Fosters Treatment Advancements for Young Lymphoma Populations

Andrew M. Evens, DO, MS
November 18th 2024
Podcast

A leader from the adolescent and young adult lymphoma space discusses how collaboration between adult and pediatric oncologists has transformed the field.

BTK Inhibitor Treatment Options Across the Lymphoma Landscape

BTK Inhibitor Treatment Options Across the Lymphoma Landscape

ONCOLOGY Staff
November 17th 2024
Article

Clinicians focused on CLL, follicular lymphoma, and MCL gathered during a Frontline Forum to discuss the use of BTKi in each respective disease state.

A panel of expert pharmacists provides their perspectives on gene therapy agents such as exagamglogene autotemcel in the management of sickle cell disease.

Leveraging Ex Vivo Gene Therapy Advancements in Hemoglobinopathies and Metabolic Diseases

Alexis K. Kuhn, PharmD, BCOP ;Katie Bruce, PharmD, BCPPS;Susie Long, PharmD
October 21st 2024
Podcast

A panel of expert pharmacists provides their perspectives on gene therapy agents such as exagamglogene autotemcel in the management of sickle cell disease.

FDA

FDA Approves Revumenib for Relapsed/Refractory KMT2A-Translocated Acute Leukemia

Gina Mauro
November 15th 2024
Article

The FDA has approved revumenib (Revuforj) for the treatment of patients with relapsed/refractory acute leukemia with a KMT2A translocation in adult and pediatric patients 1 year and older.

Developers are expected to file a supplemental NDA for revumenib in NPM1-mutated AML in the first half of 2025.

Revumenib Elicits Favorable Efficacy in mNPM1 Acute Myeloid Leukemia

Roman Fabbricatore
November 15th 2024
Article

Developers are expected to file a supplemental NDA for revumenib in NPM1-mutated AML in the first half of 2025.