Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration (FDA) <a href="https://proddocwire.wpengine.com/abstracts/hem-onc-abstracts/fda-places-point-of-care-car-t-cell-trial-on-hold/">placed a partial hold</a> on all ongoing clinical trials of venetoclax for the treatment of multiple myeloma (MM) due to an <a href="https://proddocwire.wpengine.com/rheumatology/fda-gout-drug-increases-death-risk/">excessive amount of deaths</a> in the phase III BELLINI study.Venetoclax is already approved by the FDA to treat chronic lymphocytic leukemia and acute myeloid leukemia, and these findings do not impact the use of this drug in those patient populations.Phase II trials of venetoclax in the MM population showed promising results, but the number of deaths involved in the larger BELLINI trial prompted the FDA&rsquo;s hold. Although the trial met its primary endpoint of significantly improved progression-free survival (PFS), it also showed that patients who received venetoclax were at a two-fold higher risk for death compared with those who received placebo.<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
Patients already taking venetoclax for myeloma should follow the advice of their doctors who will make a case by case decision on benefits vs risks in terms of continuing therapy, &amp; follow <a href="https://twitter.com/US_FDA?ref_src=twsrc%5Etfw">@US_FDA</a> guidance. In partial hold, patients doing well on trial are permitted to continue
&mdash; Vincent Rajkumar (@VincentRK) <a href="https://twitter.com/VincentRK/status/1109465596096376833?ref_src=twsrc%5Etfw">March 23, 2019</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The multicenter, randomized, double-blind BELLINI trial was assessing bortezomib and dexamethasone plus venetoclax or placebo in patients with relapsed/refractory MM who have received one to three prior lines of therapy and are sensitive or na&iuml;ve to proteasome inhibitors. Patients in the venetoclax cohort had improve PFS (22.4 months vs. 11.5 months; hazard ratio [HR] = 0.63, 95% CI, 0.44-0.90), as well as significant improvements in the overall response rate (82% vs. 68%).In a pre-planned analysis, 41 deaths (21.1%) were observed in the venetoclax cohort, 13 (6.7%) of which were treatment-related (HR=2.03; 95% CI, 1.042-3.945). Of these, eight were associated with an infection. Comparatively, 11 deaths (11.3%) were observed in the placebo group, one (1.0%) of which was treatment-related.<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
VERY INTRIGUING: FDA Puts Enrollment Hold on Venetoclax Myeloma Trials &ndash;&gt; better ORR (82% vs 68%) and median PFS (2x: 22 vs 11 months) in venetoclax arm vs placebo, same rate AE's/SAE's, yet double number of deaths (22% vs 11%) with VEN!<a href="https://t.co/viqxVrVBks">https://t.co/viqxVrVBks</a> via <a href="https://twitter.com/TargetedOnc?ref_src=twsrc%5Etfw">@TargetedOnc</a>
&mdash; Oscar Lahoud, MD (@DrOscarLahoud) <a href="https://twitter.com/DrOscarLahoud/status/1108829908162236416?ref_src=twsrc%5Etfw">March 21, 2019</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>

MarkAlain Déry, DO

Eric Griggs, MD

Measles in America: An Ongoing Problem

Infectious Disease

Roger Rodby, MD

Joel M. Topf, MD, FACP

Seldin Award Winner Advocates Online Education

NKF Spring Clinical Meetings 2025

Hatem Soliman, MD

The Future of Dendritic Cell Vaccines in HER2+ Breast Cancer: Toward De-Escalation of Chemotherapy

HER2 Breast Cancer

Latest News

Multiple Myeloma Trial on Hold Due to Deaths

Oncology

The U.S. Food and Drug Administration (FDA) placed a partial hold on all ongoing clinical trials of venetoclax for the treatment of multiple myeloma (MM) due to an excessive ...

About Us

Editorial Policy

Advertising

Contact Us

eNewsletters

Contribute

Career Center

MashupMD

Blood Cancers Today

Cancer Nursing Today

GU Oncology Now

Urban Health Today

Bile Duct Cancer

Colorectal Cancer

Gastroesophageal Cancer

Gastric Cancer

GEP-NETs

GIST

Liver Cancer

Pancreatic Cancer

GI Oncology Now

Anemia

Deep Vein Thrombosis

Essential Thrombocythemia

Hemophilia

Immune Thrombocytopenic Purpura

Myelodysplastic Syndromes

Myelofibrosis

Myeloproliferative Neoplasms

Polycythemia Vera

Pulmonary Embolism

Sickle Cell Disease

Thrombocytopenia

Thrombophilia

Thrombosis

Thrombotic Thrombocytopenic Purpura

Venous Thromboembolism

von Willebrand Disease

Heme Today

Acute Kidney Injury

ADPKD

Anemia and Kidney Disease

Chronic Kidney Disease

COVID-19 and Kidney Disease

Diabetes and Hypertension

End-Stage Renal Disease

Gout

Hyperkalemia

IgAN

Kidney Transplantation

Metabolic Acidosis

Nephrology Times

HR Breast Cancer

Triple-Negative Breast Cancer

Genetics & Breast Cancer

Breast Cancers Today

Atherosclerotic Disease

Atrial Fibrillation

Heart Failure

Hypertension

Interventional Cardiology

Lipid Management

Practice Tips With Dr. Lichaa

Preventive Cardiology

Stroke

Cardiology

Breast Cancer

Gynecologic Cancer

Head and Neck Cancer

Skin Cancer

Sleep

Urology

Diabetes

Ophthalmology

— Demodex Blepharitis

Neurology

Rheumatology

Gastroenterology

Pulmonology

Infectious Diseases

— HIV

Health and Wellness

Lupus

Future of Medicine

Orthopedics

Pharmacology

Career News

More

Conferences

CardioNerds

The Sleep Source With Dr. Morse

Rheumatology Rounds With Dr. Maheswaranathan

Partners

Expert Interviews

Subscribe