DUBLIN–(BUSINESS WIRE)–The “Disease Analysis: Acute Myeloid Leukemia (AML)” drug pipelines has been added to ResearchAndMarkets.com’s offering.
AML is a type of heterogeneous hematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. Acute means that the leukemia may progress rapidly – AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including the lymph nodes, spleen, central nervous system, and testicles.
The publisher estimates that in 2018, there were 158,400 incident cases of acute myeloid leukemia (AML) worldwide, and expects that number to increase to 169,000 incident cases by 2027. Approximately 60% of newly diagnosed patients are eligible for intensive chemotherapy, such as the 7+3 regimen of cytarabine and daunorubicin.
In the last three years, there have been eight new drugs approved for AML in the US, dramatically changing the treatment landscape. Gone is the era where all front-line patients received either 7+3 chemotherapy or a hypomethylating agent (decitabine or azacitidine). Many of the new therapies target specific segments of AML or patients with specific mutations. As such, there is currently little competition between the new therapies, but that will change as therapies receive label expansions and new competitor therapies are approved.
Two FLT3 inhibitors have been approved for FLT3-mutated AML: Rydapt for front-line patients eligible for intensive chemotherapy, and Xospata for relapsed/refractory patients. Rydapt may soon face competition in the front-line FLT3 setting as quizartinib and Xospata are being evaluated in combination with standard chemotherapy and as single-agent maintenance therapies following either chemotherapy consolidation or bone marrow transplant. Crenolanib is also being evaluated as maintenance therapy after standard induction chemotherapy and consolidation. Approval in the lucrative maintenance setting would give these drugs a favorable long-term commercial outlook. Approximately 25-30% of AML patients have an FLT3 mutation.
Tibsovo and Idhifa are approved as oral, single-agent therapies for relapsed/refractory AML patients with IDH1 and IDH2 mutations, respectively. Tibsovo is also approved as a monotherapy for front-line patients over the age of 75 years. Both of these IDH inhibitors are now in Phase III trials in combination with standard induction (7+3) and consolidation chemotherapy in front-line AML. In addition, Tibsovo is being investigated in combination with azacitidine in a Phase III trial recruiting front-line patients. Tibsovo may face competition from FT-2102, an IDH1 inhibitor being evaluated in the relapsed/refractory setting in a pivotal single-arm Phase II trial both as monotherapy and in combination with azacitidine. IDH1 mutations are present in 6-9% of AML, while IDH2 mutations are present in approximately 12% of cases.
Companies Mentioned
- Apollomics
- Astellas
- BerGenBio
- Chimerix
- Daiichi Sankyo
- Forma
- GlycoMimetics
- Kiadis
- MacroGenics
- Medigene
- Piramal Pharma
Key Topics Covered:
1. Overview
- Latest key takeaways
2. Disease Background
- Definition
- Patient segmentation
- Other risk factors
- Symptoms
- Diagnosis
3. Treatment
- First-line treatment of AML consists of induction and consolidation
4. Epidemiology
5. Marketed Drugs
6. Pipeline Drugs
7. Key Regulatory Events
- Xospata Reimbursement Marks a First for AML in England
- Keeping Track: Targeted Oncologics Take Center Stage, Led by Retevmo and Trabecta Approvals
- CHMP Adopts a Positive Opinion for Daurismo
- NICE Draft Guidance: Rejects Keytruda in Head & Neck Cancer, Xospata in AML
- Daiichi Sankyo Plays Long Game with Quizartinib Outside Japan
- Kiadis Crushed by EMA Rejection of T-Cell Therapy
8. Probability of Success
9. Licensing and Asset Acquisition Deals
- Agios announces that it will receive $255m from Royalty Pharma
- Gilead Calls Forty Seven Buyout Complementary to Kite, Other IO Efforts
- Apollomics Gains China-Plus Rights to GlycoMimetics’ E-Selectin Antagonists
- Finance Watch: Forma Raises $100m in Quest to become a Sickle Cell Leader
- BerGenBio, Piramal Pharma Strike Deal for Bemcentinib
- Immuno-Oncology Continues to Draw Pharma Companies to the Deal Table
- With Celgene Acquisition Closed, Bristol Faces Major Milestones
- Astellas Licenses Vector Cell Technology from RiKen
- Chimerix Licenses AML Candidate from Cantex
- Servier Deal Termination Fails to Dent MacroGenics’ Flotetuzumab Optimism
- Ono Licenses Rafael’s Novel Chemo-Sensitizing Agent for Asia
10. Clinical Trial Landscape
- Sponsors by status
- Sponsors by phase
- Recent events
11. Drug Assessment Model
12. Market Dynamics
13. Future Trends
- New drug launches, including therapies for relapsed/refractory disease, will drive growth in the AML market over the forecast period
- FLT3 inhibitors are expected to move into the first-line maintenance setting
- IDH inhibitor combinations are expected to move into earlier stages of AML
- Oral hypomethylating agents are under development in AML
14. Consensus Forecasts
15. Recent Events and Analyst Opinion
16. Key Upcoming Events
17. Key Opinion Leader Insights
18. Unmet Needs
19. Bibliography
For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/fcllcs
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