Polatuzumab vedotin-piiq is approved by USFDA for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma

Polatuzumab
For adult patients with high-grade B-cell lymphoma (HGBL), not otherwise specified (NOS), or diffuse large B-cell lymphoma (DLBCL) who have not previously received treatment and who have an International Prognostic Index (IPI) score of 2 or higher, the Food and Drug Administration has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.).

Share This Post

May 2023: For adult patients with high-grade B-cell lymphoma (HGBL), not otherwise specified (NOS), or diffuse large B-cell lymphoma (DLBCL) who have not previously received treatment and who have an International Prognostic Index (IPI) score of 2 or higher, the Food and Drug Administration has approved polatuzumab vedotin-piiq (Polivy, Genentech, Inc.).

The POLARIX (NCT03274492) trial, which included 879 patients with previously untreated large B-cell lymphoma and an IPI score of 2–5, served as the foundation for the approval. The trial assessed the superiority of replacing vincristine in the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) with polatuzumab vedotin. For six 21-day cycles, patients were randomly assigned (1:1) to receive either polatuzumab vedotin plus R-CHP (pola + R-CHP) or R-CHOP. Both arms then received two more cycles of rituximab alone. The most common diagnoses were HGBL (11%), NOS (84%) and de novo DLBCL.

The investigator-assessed progression-free survival (PFS) was used to determine effectiveness. PFS in the pola + R-CHP arm was statistically substantially longer, with a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.95; p = 0.0177). Modified event-free survival was significantly improved in this arm (HR 0.75; 95% CI: 0.58, 0.96; p=0.0244). In the final analysis, there was no discernible change in the complete response rate or overall survival (HR 0.94; 95% CI: 0.67, 1.33).

Aside from laboratory abnormalities, peripheral neuropathy, nausea, fatigue, diarrhoea, constipation, alopecia, and mucositis were the most frequent adverse reactions with pola + R-CHP (20%). Lymphopenia, neutropenia, hyperuricemia, and anaemia were grade 3 to 4 laboratory abnormalities (10%). In 53% of patients, peripheral neuropathy either formed or got worse, and in 58% of patients, it got better after a median of 4 months. 34% of patients experienced serious adverse events, including pneumonia and febrile neutropenia.

In conjunction with R-CHP, the recommended dosage of polatuzumab vedotin is 1.8 mg/kg administered intravenously every 21 days for six cycles. Antihistamine, antipyretic, and prophylactic granulocyte colony-stimulating factor administration to patients is advised.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Limkato Korea’s first CAR T Cell therapy
CAR T-Cell therapy

Limkato: Korea’s first CAR T Cell therapy

South Korea is making significant strides in **CAR T cell therapy**, highlighted by the approval of **Limkato**, the first domestically developed CAR T therapy by **Curocell** in 2023. This milestone reduces reliance on foreign treatments and boosts Korea’s position in the global biotech industry. With strong government support and cutting-edge research, Korea is poised to advance CAR T therapies further, expanding applications and improving accessibility for cancer patients.

TIL therapy for melanoma in China
Melanoma

TIL therapy for melanoma in China

Tumor-Infiltrating Lymphocyte (TIL) therapy represents a promising advancement in the treatment of melanoma, particularly in cases where traditional treatments have failed. In China, the adoption of TIL therapy is gaining momentum, offering new hope to patients battling this aggressive form of skin cancer.

Need help? Our team is ready to assist you.

We wish a speedy recovery of your dear and near one.

Start chat
We Are Online! Chat With Us!
Scan the code
Hello,

CancerFax is the most trusted online platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies.

Send your medical reports and get a free analysis.

🌟 Join us in the fight against cancer! 🌟

Привет,

CancerFax — это самая надежная онлайн-платформа, призванная предоставить людям, столкнувшимся с раком на поздних стадиях, доступ к революционным клеточным методам лечения.

Отправьте свои медицинские заключения и получите бесплатный анализ.

🌟 Присоединяйтесь к нам в борьбе с раком! 🌟