Pirtobrutinib is approved by the USFDA for chronic lymphocytic leukemia and small lymphocytic lymphoma

Pirtobrutinib is approved by the USFDA for chronic lymphocytic leukemia and small lymphocytic lymphoma

Share This Post

The Food and Drug Administration granted accelerated approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) on December 1, 2023, for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have undergone at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.

The study looked at how well it worked in BRUIN (NCT03740529), a worldwide, open-label, single-arm, multicohort trial with 108 people who had CLL or SLL and had already had at least two other treatments, including a BTK inhibitor and a BCL-2 inhibitor. Patients underwent a median of 5 previous lines of therapy, with a range from 2 to 11. Seventy-seven percent of patients stopped using the previous BTK inhibitor due to refractory or worsening illness. The drug Pirtobrutinib was given orally at a dosage of 200 mg once a day and was maintained until disease progression or unacceptable toxicity occurred.

The primary efficacy metrics were the overall response rate (ORR) and duration of response (DOR), evaluated by an independent review committee based on the 2018 iwCLL criteria. The objective response rate (ORR) was 72% with a 95% confidence interval (CI) of 63% to 80%, and the median duration of response (DOR) was 12.2 months with a 95% CI of 9.3 to 14.7. All responses were incomplete.

The most frequent side effects (≥ 20%), not including laboratory-related terms, were fatigue, bruises, cough, musculoskeletal discomfort, COVID-19, diarrhea, pneumonia, stomach pain, dyspnea, bleeding, edema, nausea, pyrexia, and headache. Grade 3 or 4 laboratory abnormalities affecting more than 10% of patients included reduced neutrophil counts, anemia, and decreased platelet counts. 32% of patients experienced severe infections, with fatal infections reported in 10% of cases. The prescribing material include cautions and advisories for infections, bleeding, cytopenias, cardiac arrhythmias, and subsequent primary cancers.

The suggested pirtobrutinib dosage is 200 mg taken orally once a day until disease progression or intolerable effects.

View full prescribing information for Jaypirca.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Adagrasib with cetuximab has received accelerated approval by FDA for KRAS G12C-mutated colorectal cancer
Colon cancer

Adagrasib with cetuximab has received accelerated approval by FDA for KRAS G12C-mutated colorectal cancer

The FDA has granted accelerated approval to Adagrasib combined with Cetuximab for treating KRAS G12C-mutated colorectal cancer. This approval is based on promising clinical trial results showing enhanced efficacy of the drug duo. Adagrasib, a KRAS inhibitor, and Cetuximab, an EGFR inhibitor, together target the cancer more effectively, offering new hope for patients with this specific genetic mutation, aiming to improve survival rates and treatment outcomes.

Pembrolizumab with chemotherapy is approved by the USFDA for primary advanced or recurrent endometrial carcinoma
Endometrial cancer

Pembrolizumab with chemotherapy is approved by the USFDA for primary advanced or recurrent endometrial carcinoma

The USFDA has approved Pembrolizumab combined with chemotherapy for treating primary advanced or recurrent endometrial carcinoma. This approval is based on clinical trial data showing significant improvements in patient outcomes. Pembrolizumab, an immune checkpoint inhibitor, works by enhancing the body’s immune response against cancer cells. This combination therapy offers a new and promising treatment option for patients facing this challenging and often aggressive 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,

Welcome to CancerFax !

CancerFax is a pioneering platform dedicated to connecting individuals facing advanced-stage cancer with groundbreaking cell therapies like CAR T-Cell therapy, TIL therapy, and clinical trials worldwide.

Let us know what we can do for you.

1) Cancer treatment abroad?
2) CAR T-Cell therapy
3) Cancer vaccine
4) Online video consultation
5) Proton therapy