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Disease Analysis: Multiple Myeloma

  • ID: 5148347
  • Report
  • May 2021
  • Region: Global
  • 134 pages
  • Pharma Intelligence
Definition

Asthma is a chronic respiratory condition characterized by recurrent wheezing, coughing, and breathlessness, which occur in acute events known as exacerbations. Often triggered by factors such as exercise, allergen or irritant exposure, change in weather, or viral respiratory infections, these flare-ups can vary significantly in frequency and severity. Attacks consist of swelling of the lining of the bronchial tubes, which narrows airways and results in a reduction of airflow into and out of the lungs. Historically considered to be a single disease, asthma is now viewed more as an overlapping assemblage of individual phenotypes with various underlying pathophysiological processes leading to symptoms.

Latest Key Takeaways
  • The publisher estimates that in 2018, there were approximately 343.6 million prevalent cases of asthma in individuals aged up to 44 years worldwide, and forecasts that number to increase to 363.7 million prevalent cases by 2027.
  • The GINA treatment strategy released in 2019 included an important change disrupting a fundamental practice in mild asthma management. Treatment with a short-acting beta 2 agonist (SABA) alone is no longer recommended for adults and adolescents with asthma. While short-acting bronchodilators may provide symptom relief for patients, they remain at risk for severe exacerbations. In late 2020, a similar, but still distinct update was made to the NAEPP guidelines.
  • The majority of approved drugs in the asthma space are inhaled small molecules, while several newer approvals show a shift towards the development of injectable biologics.
  • Since its launch as the first fixed-dose combination (FDC) of an inhaled corticosteroid (ICS) and a long-acting beta 2 agonist (LABA), GlaxoSmithKline’s Advair has become a well-established gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.
  • Novartis has ended development of its asthma drug fevipiprant following data which showed that the once-daily pill was not effective.
  • The convenience of pipeline ICS/LABA/long-acting muscarinic antagonist (LAMA) triple FDC therapies will only marginally increase the overall use of the LAMA drug class as physicians remain skeptical about the role of LAMAs in asthma.
  • Key upcoming catalysts in asthma include topline results from Phase III studies for SABA/ICS combination PT027.
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OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Risk factors
  • Presentation
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Co-morbidities
  • Subtypes
TREATMENT
  • Smoldering multiple myeloma
  • Active multiple myeloma
  • Active multiple myeloma: first line, SCT eligible
  • Active multiple myeloma: first line, SCT ineligible
  • Active multiple myeloma: first-line disease
  • Active multiple myeloma: relapsed/refractory
  • Active multiple myeloma: progressive or relapsed disease
  • Approvals for key multiple myeloma regimens
EPIDEMIOLOGY
  • Incidence methodology
MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS
  • Pfizer’s Elranatamab Among New Entrants On EMA’s PRIME
  • BMS/Bluebird Ready Abecma, First BCMA-Targeting CAR-T, For Initial Patients
  • EU Early Access For Melphalan Flufenamide
  • Early-Stage R&D In The Spotlight As BMS Patent Expirations Approach
  • EU Fast-Track Fail For Another BMS CAR-T Cell Therapy
  • EMA PRIME Wins For Bispecific Antibodies & Another Gene Therapy
  • Janssen Wins EU Fast-Track Status For CAR-T Therapy Cilta-Cel
  • Bumpy EU Review Ends Well For Selinexor Filing
  • Early FDA Approval For Karyopharm’s Xpovio
  • Krka, Accord And Xeris Pick Up European Nods
  • PharmaMar Victory Has EU Regulators Pondering Next Move
  • NICE OKs Sarclisa & Mayzent For Funding In England, But Rejects Vindaqel
  • Mylan Obtains CHMP Backing For Revlimid Generic In Two Indications
  • Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time
  • Kyprolis+Darzalex Offers Relapsed Myeloma Patients An IMiD-Free Regimen
  • GSK To Address Multiple Myeloma With First-In-Class Blenrep In EU
  • GSK’s Blenrep Wins BCMA Race, Carries Ocular Toxicity Warning
  • EMA Says Yes To GSK’s Belantamab
  • GSK’s Myeloma Drug Gets AdComm Backing, But Limitations Remain Clear
  • Concerns About Eye Toxicity Could Limit GSK’s Myeloma Drug Potential
  • Sanofi Is ‘Working On’ Resolving England’s Sarclisa Funding Concerns
  • New EU Approvals
  • Manufacturing Issues Ground bluebird/Bristol ‘Ide-Cel’ CAR-T
  • Approval For New Darzalex Dosing
  • Xpovio Avoided Complete Response Letter Through Late-Cycle Submission Of BOSTON Data
PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Wugen Aligns With Alpha Biopharma For Asia Markets
  • SELLAS Licenses Greater China Rights For Immunotherapies To 3D
  • Kiadis And Sanofi Sign Natural Killer Cell Therapy Pact
  • Bluebird Revises Business Priorities And Secures Upfront Cash From Bristol
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
  • Recent events
DRUG ASSESSMENT MODEL

MARKET DYNAMICS

FUTURE TRENDS
  • Genericization of key brands Velcade, Revlimid, and Pomalyst will substantially slow market growth
  • New BCMA-targeted therapies will contribute to growth in the multiple myeloma market over the forecast period
  • Label expansions of marketed drugs will help balance out downturn in the market
  • Drugs with a novel mechanism of action, such as Xpovio, Pepaxto, and Blenrep, will move into earlier lines of therapy
CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Darzalex for Multiple Myeloma (December 7, 2020)
  • bb21217 for Multiple Myeloma (December 5, 2020)
  • CT053 for Multiple Myeloma (December 5, 2020)
  • JNJ-4528 for Multiple Myeloma (December 5, 2020)
  • MEDI2228 for Multiple Myeloma (December 5, 2020)
  • Multiple Drugs for Multiple Myeloma (December 5, 2020)
  • RG6160 for Multiple Myeloma (December 5, 2020)
  • Teclistamab for Multiple Myeloma (December 5, 2020)
  • Talquetamab for Multiple Myeloma (December 5, 2020)
  • UCARTCS1 for Multiple Myeloma (November 17, 2020)
  • Darzalex Faspro for Multiple Myeloma (July 31, 2020)
  • Blenrep for Multiple Myeloma (July 14, 2020)
  • Blenrep for Multiple Myeloma (July 10, 2020)
  • UCARTCS1 for Multiple Myeloma (July 6, 2020)
  • Sarclisa for Multiple Myeloma (June 2, 2020)
  • CC-92480 for Multiple Myeloma (May 31, 2020)
  • Kyprolis for Multiple Myeloma (May 31, 2020)
  • Sarclisa for Multiple Myeloma (May 31, 2020)
  • Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
  • Teclistamab for Multiple Myeloma (May 29, 2020)
  • Xpovio for Multiple Myeloma (May 28, 2020)
  • Blenrep for Multiple Myeloma (May 27, 2020)
  • Abecma for Multiple Myeloma (May 13, 2020)
  • Sarclisa for Multiple Myeloma (May 12, 2020)
  • Pepaxto for Multiple Myeloma (March 26, 2020)
  • Ninlaro for Multiple Myeloma (March 10, 2020)
  • Empliciti for Multiple Myeloma (March 9, 2020)
  • Xpovio for Multiple Myeloma (March 2, 2020)
KEY UPCOMING EVENTS

KEY OPINION LEADER INSIGHTS

UNMET NEEDS

BIBLIOGRAPHY

APPENDIX

LIST OF FIGURES
Figure 1: Trends in incident cases of multiple myeloma, 2018–27
Figure 2: Overview of pipeline drugs for multiple myeloma in the US
Figure 3: Pipeline drugs for multiple myeloma, by company
Figure 4: Pipeline drugs for multiple myeloma, by drug type
Figure 5: Pipeline drugs for multiple myeloma, by classification
Figure 6: Probability of success in the multiple myeloma pipeline
Figure 7: Clinical trials in multiple myeloma
Figure 8: Top 10 drugs for clinical trials in multiple myeloma
Figure 9: Top 10 companies for clinical trials in multiple myeloma
Figure 10: Trial locations in multiple myeloma
Figure 11: Multiple myeloma trials status
Figure 12: Multiple myeloma trials sponsors, by phase
Figure 13: The publisher’s drug assessment summary for multiple myeloma
Figure 14: Market dynamics in multiple myeloma
Figure 15: Future trends in multiple myeloma
Figure 16: JNJ-4528 for Multiple Myeloma (December 5, 2020): Phase Ib/II - CARTITUDE-1 (Dose Finding)
Figure 17: Sarclisa for Multiple Myeloma (June 2, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
Figure 18: Kyprolis for Multiple Myeloma (May 31, 2020): Phase III - ECOG Study - w/Bortezomib/Lenalidomide/Dexamethasone (VRd)
Figure 19: Sarclisa for Multiple Myeloma (May 31, 2020): Phase II - GMMG-CONCEPT
Figure 20: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020): Phase I/II - EVOLVE
Figure 21: Teclistamab for Multiple Myeloma (May 29, 2020): Phase I - CR108206
Figure 22: Xpovio for Multiple Myeloma (May 28, 2020): Phase III - BOSTON
Figure 23: Blenrep for Multiple Myeloma (May 27, 2020): Phase II - DREAMM-6 (w/ Vd or Rd)
Figure 24: Sarclisa for Multiple Myeloma (May 12, 2020): Phase III - IKEMA (w/Carfilzomib+Dex)
Figure 25: Pepaxto for Multiple Myeloma (March 26, 2020): Phase II - HORIZON
Figure 26: Ninlaro for Multiple Myeloma (March 10, 2020): Phase III - TOURMALINE-MM2 (w/Len/Dex (First Line))
Figure 27: Empliciti for Multiple Myeloma (March 9, 2020): Phase III - ELOQUENT-1
Figure 28: Xpovio for Multiple Myeloma (March 2, 2020): Phase III - BOSTON
Figure 29: Key upcoming events in multiple myeloma

LIST OF TABLES
Table 1: Diagnostic criteria for MGUS and smoldering multiple myeloma
Table 2: Symptoms of advanced multiple myeloma
Table 3: ISS criteria for multiple myeloma
Table 4: R-ISS criteria for multiple myeloma
Table 5: Common co-morbidities associated with multiple myeloma
Table 6: Common cytogenetic abnormalities associated with multiple myeloma
Table 7: Recommended front-line pharmacological therapies for multiple myeloma
Table 8: NCCN recommended treatment regimens for previously treated multiple myeloma
Table 9: ESMO recommended treatment regimens for previously treated multiple myeloma
Table 10: Approvals for key multiple myeloma regimens, by country
Table 11: Incident cases of multiple myeloma, 2018–27
Table 12: Incident cases of multiple myeloma, by gender, 2018
Table 13: Marketed drugs for multiple myeloma
Table 14: Pipeline drugs for multiple myeloma in the US
Table 15: Historical global sales, by drug ($m), 2016–20
Table 16: Forecasted global sales, by drug ($m), 2021–25
Table 17: Darzalex for Multiple Myeloma (December 7, 2020)
Table 18: bb21217 for Multiple Myeloma (December 5, 2020)
Table 19: CT053 for Multiple Myeloma (December 5, 2020)
Table 20: JNJ-4528 for Multiple Myeloma (December 5, 2020)
Table 21: MEDI2228 for Multiple Myeloma (December 5, 2020)
Table 22: Multiple Drugs for Multiple Myeloma (December 5, 2020)
Table 23: RG6160 for Multiple Myeloma (December 5, 2020)
Table 24: Teclistamab for Multiple Myeloma (December 5, 2020)
Table 25: Talquetamab for Multiple Myeloma (December 5, 2020)
Table 26: UCARTCS1 for Multiple Myeloma (November 17, 2020)
Table 27: Darzalex Faspro for Multiple Myeloma (July 31, 2020)
Table 28: Blenrep for Multiple Myeloma (July 14, 2020)
Table 29: Blenrep for Multiple Myeloma (July 10, 2020)
Table 30: UCARTCS1 for Multiple Myeloma (July 6, 2020)
Table 31: Sarclisa for Multiple Myeloma (June 2, 2020)
Table 32: CC-92480 for Multiple Myeloma (May 31, 2020)
Table 33: Kyprolis for Multiple Myeloma (May 31, 2020)
Table 34: Sarclisa for Multiple Myeloma (May 31, 2020)
Table 35: Orvacabtagene Autoleucel for Multiple Myeloma (May 30, 2020)
Table 36: Teclistamab for Multiple Myeloma (May 29, 2020)
Table 37: Xpovio for Multiple Myeloma (May 28, 2020)
Table 38: Blenrep for Multiple Myeloma (May 27, 2020)
Table 39: Abecma for Multiple Myeloma (May 13, 2020)
Table 40: Sarclisa for Multiple Myeloma (May 12, 2020)
Table 41: Pepaxto for Multiple Myeloma (March 26, 2020)
Table 42: Ninlaro for Multiple Myeloma (March 10, 2020)
Table 43: Empliciti for Multiple Myeloma (March 9, 2020)
Table 44: Xpovio for Multiple Myeloma (March 2, 2020)
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