Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration granted accelerated approval to Polivy&trade; (polatuzumab vedotin-piiq), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and rituximab for adult patients with relapsed/refractory <a href="https://www.docwirenews.com/abstracts/hem-onc-abstracts/juliet-analysis-tisagenlecleucel-dlbcl/">diffuse large B-cell lymphoma</a> (DLBCL), not otherwise specified, who received at least two prior therapies.The decision was based on the multicenter, phase Ib/II GO29365 trial that included 80&nbsp;patients with <a href="https://www.docwirenews.com/conference-coverage/ash-conference-coverage/richard-maziarz-md-tisagenlecleucel-induces-durable-response-among-adults-with-pretreated-dlbcl/">relapsed/refractory DLBCL</a> who received at least one prior regimen. Patients were randomized 1:1 to receive polatuzumab vedotin-piiq in combination with bendamustine and rituximab (n=40) or bendamustine plus rituximab alone (n=40) for six 21-day cycles.<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA approves polatuzumab vedotin-piiq for diffuse large B-cell lymphoma | FDA <a href="https://t.co/8PV4snZkuV">https://t.co/8PV4snZkuV</a>
&mdash; Al-Ola A Abdallah MD (USMIRC) (@Abdallah81MD) <a href="https://twitter.com/Abdallah81MD/status/1138153814417182720?ref_src=twsrc%5Etfw">June 10, 2019</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>Polatuzumab vedotin-piiq 1.8 mg/kg was administered via intravenous infusion on day two of cycle one and on day one of subsequent cycles. Bendamustine 90&nbsp;mg/m2 was administered intravenously on days two and three of cycle one and on days one and two of subsequent cycles. Rituximab 375&nbsp;mg/m2&nbsp;was administered intravenously on day one of each cycle.After therapy, the complete response (CR) rate was 40% (95% CI, 25-57) in the cohort receiving the polatuzumab vedotin-piiq combination versus 18% (95% CI, 7-33%) in those receiving bendamustine plus rituximab alone. The best overall response rate was 63% and 25%, respectively. Of the 25 patients who achieved partial response or CR following the polatuzumab vedotin-piiq combination therapy, 16 patients (64%) had response durations of at least six months and 12 (48%) had response durations of at least 12 months.The most common adverse events (AEs) associated with polatuzumab vedotin-piiq were neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia. Serious AEs occurred in 64% of these patients, most often from infection. Cytopenia was the most common reason for treatment discontinuation (18%).<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
FDA granted accelerated approval to polatuzumab vedotin-piiq (POLIVY, Genentech) in combination w/bendamustine and a rituximab product for adults w/relapsed/refractory diffuse large B-cell <a href="https://twitter.com/hashtag/lymphoma?src=hash&amp;ref_src=twsrc%5Etfw">#lymphoma</a> after at least 2 prior therapies <a href="https://t.co/hC6bMz48Ba">https://t.co/hC6bMz48Ba</a><a href="https://twitter.com/hashtag/lymsm?src=hash&amp;ref_src=twsrc%5Etfw">#lymsm</a>
&mdash; FDA Oncology (@FDAOncology) <a href="https://twitter.com/FDAOncology/status/1138145234980880389?ref_src=twsrc%5Etfw">June 10, 2019</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>The prescribing information for polatuzumab vedotin-piiq carries warnings and precautions for peripheral neuropathy, infusion-related reactions, myelosuppression, serious and opportunistic infections, progressive multifocal leukoencephalopathy, tumor lysis syndrome, hepatotoxicity, and embryo-fetal toxicity.

MarkAlain Déry, DO

The Significant Danger Measles Pose for Unvaccinated Children

Infectious Disease

Andrew Moreno

Antithrombotic Care in Hemophilia: A Summary of Multi-Organizational Clinical Practice Guidance

Hemophilia

James Tumlin, MD

Joel M. Topf, MD, FACP

Proteinuria Remission With Sparsentan in FSGS

NKF Spring Clinical Meetings 2025

Latest News

FDA Approves Polivy™, First Chemoimmunotherapy for DLBCL

Oncology

The U.S. Food and Drug Administration granted accelerated approval to Polivy™ (polatuzumab vedotin-piiq), a CD79b-directed antibody-drug conjugate

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

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

HER2 Breast Cancer

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