MedPath

AbbVie and Roche Seek FDA Approval for Venclexta-Gazyva Combination in First-line CLL Treatment

• AbbVie and Roche have filed for FDA approval of Venclexta plus Gazyva combination therapy for previously untreated chronic lymphocytic leukemia patients with comorbidities.

• The Phase 3 CLL14 trial demonstrated significant improvement in progression-free survival with the Venclexta-Gazyva combination compared to standard chemotherapy-based treatment.

• The FDA is reviewing the application under its real-time oncology review program, with potential approval expected by year-end, targeting approximately 20,000 new patients in the US.

AbbVie and Roche have submitted a regulatory filing to the US Food and Drug Administration (FDA) seeking approval for their BCL-2 inhibitor Venclexta (venetoclax) in combination with anti-CD20 drug Gazyva (obinutuzumab) for previously untreated chronic lymphocytic leukemia (CLL) patients with coexisting medical conditions.
The application, which has received breakthrough therapy designation from the FDA, is supported by compelling data from the phase 3 CLL14 trial. Results showed that the Venclexta-Gazyva combination significantly reduced the risk of disease progression or death compared to the current standard of Gazyva plus chemotherapy.

Clinical Significance and Market Impact

The potential approval would mark a significant advancement in first-line CLL treatment, offering patients a chemotherapy-free option with a fixed-duration regimen. This differentiates it from existing treatments like the Imbruvica-Gazyva combination, which requires indefinite administration.
"Many newly-diagnosed CLL patients are ineligible for intensive chemotherapy," notes Dr. Sandra Horning, Roche's chief medical officer. "We are working closely with the agency to bring this new option to people with previously untreated chronic lymphocytic leukemia as quickly as possible."

Regulatory Review and Commercial Prospects

The FDA is evaluating the application under its real-time oncology review (RTOR) pilot program, which allows the agency to begin assessing clinical data as soon as trial results become available. This expedited review process could lead to approval before the end of the year.
The expansion into the first-line setting would open access to approximately 20,000 additional potential patients in the US alone. This represents a significant commercial opportunity for both companies, building on Venclexta's existing approvals in relapsed/refractory CLL and acute myeloid leukemia.

Growing Treatment Portfolio

Venclexta has shown promising growth, with worldwide sales reaching $344 million in the previous year, more than double its prior year performance. AbbVie projects sales to exceed $725 million this year.
The companies are further exploring Venclexta's potential through various combination studies, including:
  • Combination with Imbruvica as another chemotherapy-free option
  • Triple therapy with Imbruvica and Gazyva
  • Studies in multiple myeloma, non-Hodgkin lymphoma, and myelodysplastic syndrome
The collaboration between AbbVie and Roche involves co-marketing Venclexta in the US, while AbbVie markets it independently as Venclyxto in other regions.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

FDA Clears Roche's VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail for B-Cell Lymphoma Diagnosis

Roche's VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail receives FDA 510(k) clearance for in-situ hybridization testing.
The test aids pathologists in distinguishing B-cell malignancies from reactive responses, enabling quicker access to treatment.

FDA Approves Zolbetuximab for Gastric and Gastroesophageal Junction Cancer

The FDA has approved zolbetuximab in combination with chemotherapy for patients with HER2-negative, CLDN18.2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval was based on results from the SPOTLIGHT and GLOW trials, which demonstrated statistically significant improvements in progression-free survival and overall survival.

Lomond Therapeutics' Lonitoclax Shows Promising Safety Profile in Phase 1 Trial

Lomond Therapeutics announced positive Phase 1 clinical trial results for lonitoclax, an oral BCL-2 inhibitor, demonstrating a favorable safety profile in healthy volunteers.
The study showed robust BCL-2 inhibition without significant safety signals, suggesting potential advantages over venetoclax in tolerability and outpatient treatment feasibility.

FDA Updates: Approvals and Designations in Leukemia, Prostate Cancer, and Melanoma

Capivasertib plus abiraterone and ADT shows improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer.
LBS-007 receives FDA fast track designation for acute myeloid leukemia treatment based on promising early response data from a phase 1/2 trial.

FDA Grants Breakthrough Therapy Designation to RP1 Plus Nivolumab for Advanced Melanoma

The FDA granted Breakthrough Therapy Designation to vusolimogene oderparepvec (RP1) combined with nivolumab for advanced melanoma after anti-PD-1 therapy failure.
A Biologics License Application (BLA) has been submitted for RP1 with nivolumab under the Accelerated Approval pathway for previously treated advanced melanoma.

FDA Approves Zolbetuximab for HER2-Negative Gastric and GEJ Adenocarcinoma

The FDA has approved zolbetuximab-clzb (Vyloy) in combination with chemotherapy for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Approval was based on the SPOTLIGHT and GLOW trials, which demonstrated statistically significant improvements in progression-free and overall survival.

FDA Approves Lazertinib Plus Amivantamab for First-Line EGFR-Mutated NSCLC

The FDA has approved lazertinib (LECLAZA) in combination with amivantamab (RYBREVANT) as a first-line treatment for NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
The approval was based on the Phase 3 MARIPOSA study, which demonstrated a 30% reduction in the risk of disease progression or death compared to osimertinib.

FDA Approves Rybrevant Plus Lazcluze for EGFR-Mutated Advanced NSCLC

The FDA has approved Rybrevant plus Lazcluze as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations.
This combination marks the first chemotherapy-free regimen demonstrating superiority over osimertinib in patients with EGFR exon 19 deletions or exon 21 L858R substitution mutations.

Acalabrutinib, Venetoclax, and Obinutuzumab Show Promise in Frontline CLL Treatment

Acalabrutinib, venetoclax, and obinutuzumab demonstrate a high level of activity and a favorable tolerability profile in previously untreated chronic lymphocytic leukemia (CLL).
The triplet therapy allows for a shorter, more convenient 4-week venetoclax dose ramp-up, compared to the traditional 5-week ramp-up, through initial tumor debulking.

Reference News

[1]
AbbVie/Roche seek first-line CLL use for Venclexta combo
pharmaphorum.com · Mar 6, 2019
© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy