Today, the FDA also approved the first companion diagnostic test (cobas EGFR
Mutation Test v2) to detect the type of EGFR
resistance mutation that Tagrisso is known to target.
The approval of TAGRISSO(TM) with the cobas EGFR
Mutation Test v2 companion diagnostic exemplifies our focus and commitment to advancing personalized medicines in lung cancer by bringing new treatment options to patients and physicians.
5) Activating EGFR
gene mutations have been identified in different histologic types of lung cancer and are most commonly seen in adenocarcinomas (Figure 1a and b) with bronchoalveolar features or those mixed carcinomas with an adenocarcinoma component.
Testing for EGFR
mutations is believed to be the largest segment in companion diagnostics for personalized medicine.
Rociletinib targets the activating mutations of EGFR
(L858R and Del19), while also inhibiting the dominant acquired resistance mutation, T790M, which develops in approximately 60 percent of patients treated with first- and second-generation EGFR
inhibitors, while sparing wild-type, or "normal" EGFR
at anticipated therapeutic doses.
Bis[sulfosuccinimidyl]suberate (BS3), PP2, and bosutinib (the latter two being Src kinase inhibitors) and compound 56 (C56; an EGFR
inhibitor) were obtained from Calbiochem (San Diego, CA, USA).
Levine notes that these findings may apply to many different types of cancers, especially those that rely on EGFR
(or related signaling molecules) for their rapid growth.
In 2009, the first report of a clinical trial (IRESSA Pan-Asia Study) was published in which a better response rate and progression-free survival with gefitinib therapy was observed, compared to conventional chemotherapy, in patients whose advanced-stage NSCLC had EGFR
The use of Tarceva in people with EGFR
activating mutation positive advanced NSCLC is supported by a number of studies including two Phase III trials that span both Western and Asian populations.
Using lung cancer cell lines, the investigators learned that EGFR
preferentially to cancer cells over-expressing EGFR
, whereas the currently
In the first feature article, Christopher Jackson provides an overview of the biological basis for targeting EGFR
and highlights some of the important preclinical data relevant to gastrointestinal cancers.