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Updated: May 9, 2026

Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib

Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib

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Dabrafenib: first global approval.

Anita D Ballantyne¹, Karly P Garnock-Jones

¹Adis R & D Insight, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754 Auckland, New Zealand. dru@adis.com

|July 25, 2013

Summary

This summary is machine-generated.

Dabrafenib is a BRAF kinase inhibitor approved for treating metastatic melanoma with BRAF V600E mutations. Its development milestones and companion diagnostic test are summarized.

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Area of Science:

Oncology
Pharmacology
Genetics

Background:

Mutations in the BRAF gene drive cancer cell growth and proliferation.
BRAF mutations are found in 50% of malignant melanoma cases.
Dabrafenib targets mutant BRAF kinase activity for cancer treatment.

Purpose of the Study:

To summarize the development milestones of dabrafenib.
To highlight its first approval as a single-agent treatment for metastatic melanoma with BRAF V600E mutation.
To introduce the companion diagnostic test for BRAF V600E/K mutations.

Main Methods:

Review of GlaxoSmithKline's research and development program for dabrafenib.
Summary of clinical trial phases (Phase II and III) and regulatory submissions.
Description of the development of a molecular theranostic test for BRAF mutations.

Main Results:

Dabrafenib (Tafinlar®) is approved in the US as a single agent for unresectable or metastatic melanoma with BRAF V600E mutation.
Positive opinion received in the EU for the same indication.
Submissions for combination therapy with trametinib are ongoing.
Global Phase III trials and Phase II trials for brain metastases, colorectal, and non-small cell lung cancers are in progress.

Conclusions:

Dabrafenib represents a significant advancement in targeted therapy for BRAF-mutated melanoma.
The development of a companion diagnostic test ensures appropriate patient selection.
Ongoing research explores dabrafenib's efficacy in various cancer types and treatment combinations.