Dasatinib
- Generic Name
- Dasatinib
- Brand Names
- Sprycel
- Drug Type
- Small Molecule
- Chemical Formula
- C22H26ClN7O2S
- CAS Number
- 302962-49-8
- Unique Ingredient Identifier
- X78UG0A0RN
- Background
Dasatinib is an orally available multikinase inhibitor indicated for the treatment of Philadelphia chromosome (Ph)-positive leukemias. Ph is a chromosomal abnormality found in patients with chronic myelogenous leukemia (CML) and acute lymphocytic leukemia (ALL), where the ABL tyrosine kinase and the breakpoint cluster region (BCR) gene transcribe the chimeric protein BCR-ABL. BCR-ABL is associated with the uncontrolled activity of the ABL tyrosine kinase and is involved in the pathogenesis of CML and 15-30% of ALL cases. Dasatinib also inhibits a spectrum of kinases involved in cancer, including several SRC-family kinases.
Unlike imatinib, another tyrosine kinase used for the treatment of CML and Ph-positive ALL, dasatinib inhibits the active and inactive conformations of the ABL kinase domain. Also, mutations in the kinase domain of BCR-ABL may lead to relapse during imatinib treatment. Since dasatinib does not interact with some of the residues involved in those mutations, the use of this drug represents a therapeutic alternative for patients with cancers that have developed imatinib-resistance. The use of dasatinib was first approved by the FDA in 2006.
- Indication
Dasatinib is indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, as well as adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib, and adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib is also indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase or newly diagnosed Ph+ ALL in combination with chemotherapy.
- Associated Conditions
- Accelerated Phase Chronic Myelogenous Leukemia (CML), Acute Lymphoblastic Leukaemias (ALL), Chronic Phase Chronic Myeloid Leukemia, Blast phase Chronic myeloid leukemia
FDA Sets October 2025 PDUFA Date for Xspray Pharma's Resubmitted Dasynoc Application
• The FDA has acknowledged Xspray Pharma's resubmitted New Drug Application for Dasynoc, setting a PDUFA decision date of October 7, 2025.
• Dasynoc is an amorphous dasatinib formulation developed for treating chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), with potential advantages over existing treatment options.
• The resubmission addresses a Complete Response Letter received in July 2024, with Xspray confirming it has sufficient funding to support the product through approval regardless of FDA review timeline.
Biocon Pharma Secures FDA Approval for Norepinephrine Bitartrate Injection for Acute Hypotension
• Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received FDA approval for Norepinephrine Bitartrate Injection USP, used to raise blood pressure in adults with acute hypotension.
• The approved product is packaged as a 4 mg/4 mL (1 mg/mL) single-dose vial and serves as a critical treatment in emergency medical and intensive care settings.
• This approval strengthens Biocon's growing portfolio of complex drug products and expands its presence in the U.S. pharmaceutical market, particularly in the complex injectables segment.
Lupin Launches Generic Rivaroxaban in US Market Following FDA Approval
• Lupin has launched Rivaroxaban Tablets USP, 2.5 mg in the US market after receiving final approval from the FDA for its Abbreviated New Drug Application.
• The generic equivalent of Janssen's Xarelto® targets patients with coronary artery disease and peripheral artery disease, with estimated annual US sales of $446 million.
• This strategic launch strengthens Lupin's position in the high-value anticoagulant market, following the company's strong Q3 performance with a 38.8% increase in profit.
Biocon Pharma Secures FDA Approval for Generic Cancer and Blood Disorder Treatments
• Biocon Pharma Limited has received FDA approval for generic Lenalidomide capsules in six strengths, expanding treatment options for multiple myeloma and other blood disorders.
• The company gained approval for Dasatinib tablets in six different strengths, providing an alternative therapy for chronic myeloid leukemia and acute lymphoblastic leukemia patients.
• A tentative approval for Rivaroxaban tablets was also secured, positioning Biocon to offer treatment options for deep vein thrombosis and stroke prevention in atrial fibrillation patients.
Zydus Launches ANVIMO: Game-Changing CMV Prevention Drug for Transplant Patients at 91% Lower Cost
• Zydus Lifesciences introduces ANVIMO (letermovir) in India, offering a breakthrough treatment for preventing Cytomegalovirus infection in stem cell and kidney transplant patients.
• The new drug demonstrates superior safety profile and reduced side effects compared to traditional treatments, while maintaining bioequivalence with the reference drug.
• ANVIMO's launch dramatically reduces treatment costs by 91% compared to imported alternatives, making critical CMV prophylaxis more accessible to Indian transplant patients.
Blinatumomab Approved for Consolidation Therapy in CD19-Positive B-ALL, Regardless of MRD Status
• The FDA approved blinatumomab in June 2024 for CD19-positive, Philadelphia chromosome-negative B-ALL consolidation, expanding its use in both adult and pediatric patients.
• ECOG-ACRIN E1910 trial data supported the approval, showing superior overall survival with blinatumomab plus chemotherapy compared to chemotherapy alone.
• Blinatumomab is now a standard component of consolidation therapy, irrespective of a patient's minimal residual disease (MRD) status or backbone chemotherapy.
• Research continues to refine blinatumomab's role, exploring optimal patient selection, treatment sequencing, and the necessity of allogeneic stem cell transplant.
Novartis' 'Wild Card' Drug Scemblix Receives FDA Approval for Leukaemia Treatment
Novartis has secured FDA approval for Scemblix, a novel STAMP inhibitor, offering new hope for patients with previously-treated chronic myeloid leukaemia (CML). The drug has shown promising results in clinical trials, particularly for patients with the T315I mutation, and could significantly impact Novartis' CML portfolio.
Non-ABL1 Mutations Impact Outcomes in Chronic Myeloid Leukemia
• Analysis of CML patients reveals that non-ABL1 mutations, such as ASXL1 and RUNX1, can influence disease progression and treatment response.
• The study used next-generation sequencing to assess the impact of these mutations on overall survival, event-free survival, and failure-free survival in CML patients.
• Findings suggest that identifying non-ABL1 mutations could help personalize treatment strategies and improve long-term outcomes for CML patients.
• The research highlights the importance of continuous monitoring and understanding of factors affecting treatment outcomes in CML.
Olverembatinib Shows Promise as Second-Line Therapy for Chronic Phase CML
• Olverembatinib demonstrates notable efficacy in patients with chronic phase chronic myeloid leukemia (CP-CML) who are resistant or intolerant to first-line TKIs.
• The study showed that 74.1% of efficacy-evaluable patients achieved complete cytogenetic response (CCyR), and 40.6% experienced major molecular response (MMR).
• Patients pretreated with second-generation TKIs as first-line treatment achieved a CCyR of 78.9% and an MMR of 43.5% with Olverembatinib.
• Olverembatinib's safety profile was consistent with previous reports, suggesting it may be a viable second-line treatment option.
CHMP Recommends Opdivo Plus Yervoy for First-Line Treatment of Advanced Liver and Colorectal Cancers
• The CHMP has recommended Opdivo plus Yervoy for first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) based on the CheckMate -9DW trial.
• CheckMate -8HW trial results showed a 79% reduction in disease progression or death risk compared to chemotherapy for microsatellite instability-high/mismatch repair deficient colorectal cancer.
• The European Commission will review the CHMP's recommendation, potentially expanding treatment options for these cancers in the European Union.
• Opdivo plus Yervoy has shown statistically significant improvements in overall survival and objective response rate compared to existing therapies.
Novel Therapies Show Promise in Relapsed/Refractory CLL After BTK Inhibitor and Venetoclax Failure
• Emerging data highlight the increasing need for effective treatments for chronic lymphocytic leukemia (CLL) patients who progress after covalent BTK inhibitors and venetoclax.
• Lisocabtagene ciloleucel (liso-cel; Breyanzi) has received FDA approval for CLL patients with 2 or more prior lines of therapy, demonstrating a complete response rate in a subset of patients.
• BTK degraders like BGB-16673 and NX-5948 are showing promising early results in relapsed/refractory CLL, including those with BTK mutations, with manageable safety profiles.
• Bispecific antibodies such as epcoritamab-bysp (Epkinly) are also demonstrating encouraging response rates in heavily pre-treated CLL patients, offering a potential new treatment avenue.
Bristol-Myers Squibb Gains Momentum with Strong Earnings and Insider Confidence
• Bristol-Myers Squibb (BMY) stock surged following positive Q3 earnings, driven by strong sales of Eliquis and Opdivo, exceeding revenue expectations by 5.8%.
• The company received FDA approval for Cobenfy, a novel schizophrenia treatment, marking a significant return to neuroscience after decades.
• A top insider, CMO Samit Hirawat, demonstrated confidence by purchasing approximately $100,000 worth of BMY stock, signaling a bullish outlook.
• Despite mixed analyst ratings, Bristol-Myers Squibb's attractive dividend yield and growth potential make it a compelling option for investors.
FDA Approves Scemblix as First-Line Treatment for Chronic Myeloid Leukemia
• The FDA has granted accelerated approval to Novartis' Scemblix (asciminib) for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
• Scemblix, a STAMP inhibitor, demonstrated superior major molecular response rates compared to traditional tyrosine kinase inhibitors (TKIs) in the ASC4FIRST trial.
• This approval expands the eligible patient population for Scemblix and offers a potentially safer and more effective alternative to existing first-line CML treatments.
• Novartis is conducting further trials to confirm Scemblix's benefits, with potential for blockbuster sales and global market expansion.
Tailored TKI Dosing Strategies Improve Outcomes in Chronic Myeloid Leukemia
• Tailored dosing of tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML) improves safety without compromising efficacy, according to Elias Jabbour, MD.
• The phase 4 BYOND trial demonstrated that bosutinib is effective with sustained responses and manageable adverse effects in TKI-pretreated CML patients.
• Treatment-free remission is achievable with bosutinib, similar to other TKIs, when patients achieve a sustained deep molecular response.
• Novel agents and strategies are being explored to induce higher rates of sustained deep molecular response, improve long-term safety, and reduce the financial burden of CML treatment.
Xspray Pharma Plans Dasynoc NDA Resubmission After Positive FDA Meeting
• Xspray Pharma plans to resubmit its New Drug Application (NDA) for Dasynoc in Q4 2024, following constructive feedback from the FDA.
• The FDA recommended minor adjustments to Dasynoc's tablet strengths to mitigate medication errors, with new batches already in production.
• Dasynoc's pH-independent formulation addresses absorption challenges in cancer patients using pH-altering medications, ensuring consistent treatment.
• If the FDA grants a two-month review, Dasynoc's launch could occur as early as Q1 2025, offering a more reliable treatment option.
FDA Issues Complete Response Letter for Xspray Pharma's Dasynoc in CML and ALL
• The FDA issued a Complete Response Letter (CRL) for Dasynoc, Xspray Pharma's treatment for chronic myeloid leukemia (CML) and acute lymphocytic leukemia (ALL).
• The FDA requests additional labeling information and pre-approval inspection details, but does not question stability or clinical data.
• Dasynoc leverages Xspray’s HyNap technology, offering potential benefits such as lower dosing and co-administration with acid-reducing agents.
• Xspray Pharma is working to address the FDA's requests and anticipates providing an updated timeline for NDA resubmission soon.
Novartis' Scemblix Demonstrates Superior Efficacy in Newly Diagnosed CML Patients
• The Phase III ASC4FIRST trial showed Scemblix achieved a 67.7% major molecular response (MMR) rate at week 48, significantly outperforming standard-of-care TKIs.
• Scemblix demonstrated a favorable safety profile with fewer Grade 3 or worse adverse events compared to standard-of-care treatments like imatinib.
• Novartis plans to submit the ASC4FIRST data to the FDA for review under the Oncology Center of Excellence Real-Time Oncology Review program.
• Scemblix represents a promising first-line treatment option for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia patients.
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