How effective is Tabrecta?

Q: How effective is Tabrecta?

In clinical studies, the overall response rate (ORR) for Tebrecta in 60 participants who had never received any treatment for non-small cell lung cancer (NSCLC) was 68%, with half of patients having a duration of response lasting 16.6 months.

Official answer

by Drugs.com

Key Points

In Phase 2 studies, the overall response rate (ORR) for Tabrecta in 60 participants who had never received any treatment for non-small cell lung cancer (NSCLC) was 68%, with half of patients having a duration of response lasting 16.6 months.

Close to 7 out of 10 (68%) people had their tumors shrink or disappear, which is the overall response rate.

Of the responders, 5% had a complete response and 63% had a partial response.

The median duration of response for Tabrecta was 16.6 months (half responded for more than 16.6 months and half responded for less than 16.6 months).

In another study in patients who had previously received cancer treatment for NSCLC, 44% of 100 people (more than 4 of 10) had a partial response with Tabrecta, with no one having a complete response. The median duration of response for Tabrecta in this patient group was 9.7 months.

What is an Overall Response Rate?

The Overall Response Rate (ORR) determines the number of people whose tumors became smaller or fewer in number (which is called a partial response), and the number of people whose tumors disappeared completely (which is called a complete response). A complete response is not the same thing as a cure.

What does Duration of Response mean?

Duration of response is how long the cancer responds to treatment without it growing or spreading in the body.

What is Tabrecta used for?

Tabrecta (generic name: capmatinib), a kinase inhibitor from Novartis, is approved by the FDA for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with specific mutations (MET exon 14 skipping), as detected by an FDA-approved test. Tabrecta can be used as a first time treatment or in previously treated patients.

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. About 4,000 to 5,000 of patients in the U.S. with metastatic NSCLC are found to have this mutation each year. Metastatic means the cancer has spread in the body.

The recommended dose of Tabrecta is 400 mg orally twice daily (with or without food). Swallow your tablets whole; do not break, chew, or crush them.

Common side effects with Tabrecta include:

leg swelling (edema)

nausea

muscle pain, body aches

fatigue (extremely tired)

vomiting

shortness of breath

cough

decreased appetite

Tabrecta may also cause sun sensitivity, so apply a sunscreen, limit your time in the sun and wear sun protective clothing.

What is MET exon 14 skipping?

Certain genes in the body may contain abnormal changes (mutations) that can be linked to metastatic non-small cell lung cancer (mNSCLC) growth. MET exon 14 skipping is caused by non-inherited mutations in the DNA gene that make a protein called MET (mesenchymal-epithelial transition).

Your doctor can order a special biomarker test approved by the FDA to determine if you have the type of lung cancer that exhibits MET exon 14 skipping. Testing can be done on a blood sample or from a tissue biopsy. Your doctor may be able to reuse a previous tissue biopsy, if you have had one.

This is not all the information you need to know about Tabrecta (capmatinib) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss any questions you have with your doctor or other health care provider.

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.