DUBLIN, April 14, 2021 /PRNewswire/ -- The "Disease Analysis: Acute Myeloid Leukemia (AML)" report 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.
Latest Key Takeaways
Relapsed/refractory AML remains an area of unmet need, and new therapies are being developed. Not including FLT3 or IDH inhibitors, there are currently five late-stage therapies being evaluated for this setting (devimistat, DFP-10917, flotetuzumab, Iomab-B, and uproleselan).
Key recent events include the approval of Onureg and presentation of numerical data from Venclexta's VIALE-A trial. There were Phase III failures for Helsinn's pracinostat combined with azacitidine in the newly diagnosed setting and for Roche's idasanutlin and Otsuka's guadecitabine in the relapsed/refractory setting. Other Phase III failures include trials evaluting Xospata combined with azacitidine and Daurismo combined with intensive chemotherapy in front-line AML, and an Idhifa monotherapy trial in the third- and fourth-line setting.
Key upcoming catalysts for 2021 include topline results from Phase III trials for devimistat, Iomab-B, uproleselan, and Zeltherva, and a possible NDA submission for FT-2102.
The overall likelihood of approval of a Phase I AML asset is 6.3%, and the average probability a drug advances from Phase III is 50%. AML drugs, on average, take 10.8 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
Key Topics Covered:
OVERVIEW
- Latest key takeaways
DISEASE BACKGROUND
- Definition
- Patient segmentation
- Other risk factors
- Symptoms
- Diagnosis
TREATMENT
- First-line treatment of AML consists of induction and consolidation
EPIDEMIOLOGY
- Incidence methodology
MARKETED DRUGS
PIPELINE DRUGS
KEY REGULATORY EVENTS
- Oncology, Rare Disease Drugs Dominate New China Approvals
- Agios Withdraws MAA for Tibsovo
- Onureg Offers New Dose Form, New Therapy Setting For Azacitidine
- 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
PROBABILITY OF SUCCESS
LICENSING AND ASSET ACQUISITION DEALS
- Agios Sells Cancer Portfolio To Servier To Focus On Genetic Diseases
- Ireland's ONK Expands To US, Options Three NK Candidates
- Syros Obtains Arsenic-Based Leukemia Candidate From Orsenix
- Vor Hopes NCI's CAR-T Candidate Is Synergistic With Lead AML Therapy
- Kite Will Partner With HiFiBiO On AML Discovery Efforts
- 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
CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Recent events
DRUG ASSESSMENT MODEL
MARKET DYNAMICS
FUTURE TRENDS
- Venclexta is set to become a blockbuster in AML
- Immunomodulators are being developed for AML
- 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
CONSENSUS FORECASTS
RECENT EVENTS AND ANALYST OPINION
- Xospata for AML (December 21, 2020)
- Magrolimab for AML (December 6, 2020)
- Venclexta for AML (December 6, 2020)
- Actimab-A for AML (December 5, 2020)
- KO-539 for AML (December 5, 2020)
- SY-1425 for AML (December 5, 2020)
- Motixafortide for AML (November 23, 2020)
- Guadecitabine for AML (October 14, 2020)
- Idhifa for AML (August 25, 2020)
- Pracinostat for AML (July 2, 2020)
- Venclexta for AML (June 5, 2020)
- Pevonedistat for AML (May 29, 2020)
- Venclexta for AML (May 28, 2020)
- Idasanutlin for AML (March 31, 2020)
- Venclexta for AML (March 23, 2020)
- Venclexta for AML (February 28, 2020)
- Onureg for AML (December 10, 2019)
- Eprenetapopt for AML (December 9, 2019)
- Flotetuzumab for AML (December 9, 2019)
- Keytruda for AML (December 9, 2019)
- Magrolimab for AML (December 9, 2019)
- MBG453 for AML (December 9, 2019)
- Vidaza for AML (December 9, 2019)
- BST-236 for AML (December 7, 2019)
- Cusatuzumab for AML (December 7, 2019)
- Vosaroxin for AML (December 6, 2019)
- Onureg for AML (September 12, 2019)
- Pracinostat for AML (July 31, 2019)
- DSTAT for AML (July 31, 2019)
- Magrolimab for AML (July 11, 2019)
KEY UPCOMING EVENTS
KEY OPINION LEADER INSIGHTS
UNMET NEEDS
BIBLIOGRAPHY
- Prescription information
APPENDIX
Companies Mentioned
- Apollomics
- Astellas
- BerGenBio
- Chimerix
- Daiichi Sankyo
- Forma
- GlycoMimetics
- Kiadis
- MacroGenics
- Medigene
- Piramal Pharma
For more information about this report visit https://www.researchandmarkets.com/r/nkkqbh
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