Chronic Lymphocytic Leukemia (CLL) Report 2021: Treatments, Epidemiology, Marketed Drugs, Pipeline Drugs, Regulatory Events, Clinical Trials, Drug Assessment, Future Trends

DUBLIN, July 6, 2021 /PRNewswire/ — The «Chronic Lymphocytic Leukemia (CLL)» report has been added to ResearchAndMarkets.com’s offering.
The publisher estimates…

DUBLIN, July 6, 2021 /PRNewswire/ — The «Chronic Lymphocytic Leukemia (CLL)» report has been added to ResearchAndMarkets.com’s offering.

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The publisher estimates that in 2018, there were 86,900 incident cases of chronic lymphocytic leukemia (CLL) worldwide, and expects that number to increase to 91,000 incident cases by 2027.

Chronic lymphocytic leukemia (CLL) is a disorder where the bone marrow produces B lymphocytes that are morphologically mature but immunologically less mature. These lymphocytes do not fight infection as well and survive longer than normal lymphocytes, and therefore accumulate in the bone marrow, peripheral blood, and lymph nodes.

CLL diagnosis is usually confirmed by evaluating lymphocytic morphology, by the presence of a specific immunophenotype (CD5-positive and CD23-positive B cells), and by a monoclonal B lymphocyte count in the peripheral blood of at least 5,000 cells per microliter for a minimum of three months.

Key recent events include the approval of Calquence in Europe (November 2020) and Japan (January 2021), and Phase III readouts for Calquence (ELEVATE-RR trial), Ukoniq + ublituximab (UNITY-CLL), and Brukinsa (ALPINE).

Key upcoming catalysts for the next 12 months include approval of Ukoniq + ublituximab, and pivotal trial readouts for Brukinsa (SEQUOIA) and Imbruvica + Venclexta (GLOW).

The overall likelihood of approval of a Phase I CLL/SLL asset is 12.1%, and the average probability a drug advances from Phase III is 68.4%. CLL/SLL drugs, on average, take 9.7 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
  • Symptoms
  • Diagnosis
  • Patient segmentation
  • Adverse prognostic factors
  • Favorable prognostic factors

TREATMENT

  • Referral is based on disease stage, patient age, and mutation status
  • Only patients with progressive disease require therapy
  • HSCT is rarely used in CLL

EPIDEMIOLOGY

  • Incidence methodology

MARKETED DRUGS



PIPELINE DRUGS



KEY REGULATORY EVENTS

  • Natco Claims Sole Exclusivity For Ibrutinib Tablets
  • Zydus Gets Nod For First Generic Ibrutinib Capsules
  • AstraZeneca Wins Funding In England For First & Second Line Leukemia Drug
  • AstraZeneca’s Calquence Approved For Leukemia in Japan
  • Amgen Has US Rituximab Nod – But No RA Indication
  • Sandoz Egypt Partners Up To Launch Rituximab Biosimilar
  • Lilly And Innovent’s Rituximab Gets Chinese Nod
  • China Approves More Drugs For Cancer, Rare Diseases

PROBABILITY OF SUCCESS



CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL



MARKET DYNAMICS



FUTURE TRENDS

  • BTK inhibitors will continue to dominate first-line CLL, but Imbruvica will face increasing competition from second-generation therapies
  • Venclexta may see further uptake in the first-line setting if MRD negativity can translate into durable remissions
  • Reversible BTK inhibitors will disrupt the third-line setting
  • The PI3K inhibitors Zydelig and Copiktra will lose market share to Ukoniq combo
  • CAR-T therapy will offer a new option for R/R high-risk CLL patients

CONSENSUS FORECASTS



RECENT EVENTS AND ANALYST OPINION

  • Brukinsa for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (April 28, 2021)
  • Imbruvica for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (April 8, 2021)
  • Breyanzi for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 7, 2020)
  • Cirmtuzumab for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 7, 2020)
  • Pirtobrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 7, 2020)
  • TG-1303 for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 7, 2020)
  • TG-1303 for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (May 5, 2020)
  • Pirtobrutinib for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 8, 2019)
  • Ukoniq for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 8, 2019)
  • Calquence for Chronic Lymphocytic Leukemia (CLL)/Small Cell Lymphocytic Lymphoma (SLL) – NHL (December 7, 2019)

KEY UPCOMING EVENTS



KEY OPINION LEADER INSIGHTS



UNMET NEEDS



BIBLIOGRAPHY



For more information about this report visit https://www.researchandmarkets.com/r/kfhlzz

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