Accelerated approval is granted by FDA to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer

Share This Post

August 2022: For adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have a mutation resulting in mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test, the Food and Drug Administration gave capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) regular approval.

Capmatinib was given fast approval for the same use on May 6, 2020, based on the overall response rate and length of response in the GEOMETRY mono-1 trial (NCT02414139), a multicenter, non-randomized, open-label, multi-cohort research study. Based on data from an additional 63 patients and an additional 22 months of follow-up to evaluate response durability and confirm therapeutic benefit, the conversion to regular approval was made.

160 patients with advanced NSCLC with a mutation skipping exon 14 of MET showed efficacy. Patients received capmatinib 400 mg twice a day until their disease progressed or the side effects became intolerable.

A Blinded Independent Review Committee (BIRC) determined the ORR and duration of response (DOR) as the major efficacy measures (BIRC). 60 individuals who had never received treatment had an ORR of 68% (95% CI: 55, 80) and a DOR of 16.6 months (95% CI: 8.4, 22.1). The ORR was 44% (95% CI: 34, 54) among 100 patients who had previously received treatment, and the DOR was 9.7 months (95% CI: 5.6, 13).

The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% were white, 61% never smoked, 83% had adenocarcinoma, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.

Patients experienced edoema, nausea, musculoskeletal pain, weariness, vomiting, dyspnea, coughing, and decreased appetite the most frequently (20%).

Capmatinib should be taken orally twice daily at a dose of 400 mg, with or without meals.

View full prescribing information for Enhertu.

Subscribe To Our Newsletter

Get updates and never miss a blog from Cancerfax

More To Explore

Seattle Children's Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients
CAR T-Cell therapy

Seattle Children’s Hospital to Start CAR T-Cell Clinical Trial for Pediatric Lupus Patients

Seattle Children’s Hospital is launching a groundbreaking CAR T-cell clinical trial for pediatric lupus patients. This innovative approach harnesses the body’s immune cells to target and eliminate lupus-affected cells, offering new hope for young patients with this autoimmune disorder. The trial represents a significant advancement in lupus treatment, aiming to improve outcomes and reduce long-term complications for children suffering from this challenging condition.

Efficacy of CAR T Cell Therapy in B-Cell lymphoma Richter Transformation
CAR T-Cell therapy

Efficacy of CAR T Cell Therapy in B-Cell lymphoma Richter Transformation

CAR T cell therapy has shown promising efficacy in treating B-cell lymphoma Richter Transformation, a rare and aggressive disease. This advanced therapy involves genetically modifying a patient’s T cells to target and destroy cancerous B cells. Clinical trials indicate significant response rates, with some patients achieving complete remission. Despite challenges like potential severe side effects, CAR T cell therapy represents a groundbreaking approach, offering hope for improved outcomes in this difficult-to-treat condition.

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