Oct 20, 2018 | Updated: 04:34 PM EDT

ASCO Releases New Guidelines For Cancer Gene Tests

Sep 02, 2015 12:46 AM EDT

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The American Society of Clinical Oncology (ASCO) has updated this week its guidelines for treating advanced lung cancer. The updated ASCO recommendation incorporates the latest knowledge around predictive markers and also recommends the recently approved personalized treatments. Among the new recommendations are included ROS1-guided precision options, EGFR and ALK.

The last update came six years ago, in the year 2009, at a time when there wasn't much information available. The data was just preliminary and there wasn't information at all on rearrangements (ALK) and mutations (EGFR).

According to the co-chair of the ASCO expert panel that published the guidelines in the Journal of Clinical Oncology, Gregory Masters, in his interview for GenomeWeb he explained that in the 2009 guidelines was also not included information on how doctors should treat NSCLC patients with ROS1 rearrangements. The new recommendations cover treatment options for first-, second- and third-line treatment of patients with Stage IV non-small cell lung cancer.

The US Food and Drug Administration (FDA) has green-lighted a number of precision medicine options for advanced NSCLC patients since the 2011 approval of the first ALK inhibitor Xalkori (crizotinib).

For instance, in case that patients with ALK rearrangements stop responding to the drug Xalkori, the FDA approved Novartis' Zykadia (ceritinib). ASCO recommends now that in case of NSCLC patients doctors should offer advanced therapy options such as ALK rearrangements chemotherapy or Zykadia.

Advanced NSCLC patients with EGFR mutations have three FDA-approved options for the first-line setting: Gilotrif (afatinib), Tarceva (erlotinib) and Iressa (gefitinib). They are recommended accordingly by the ASCO's new guidelines.

For instance, Iressa re-entered the U.S. market just this summer, after a 10-year absence. Published data support the drug's approval last January. This has happened just in time for the cutoff of ASCO panel's literature review. The expert panel studied the literature published between January 2007 and February 2014.

In one instance, the guidelines and research have outpaced the options approved by the FDA. Xalkori sponsor Pfizer, based on data from a Phase I study, is pursuing approval of the drug as a treatment for NSCLC patients that have ROS1-positive tumors. Preliminary data from this research were already reported at ASCO's annual meeting two years ago.

Pfizer announced in April this year that it had received breakthrough therapy designation from the FDA for Xalkori as a treatment option for the ROS1-positive NSCLC. Ahead of its approval, however, ASCO already recommends now Xalkori as a first-line option for patients with Stage IV NSCLC and ROS1 rearrangements.

It becomes evident now that between the literature review cut-off and the release of the guidelines, given the rapid pace of genomics research in oncology, there have been made advances in the field of immunotherapy and published new research on additional mutations. 

According to Masters, ASCO tried to recognize that there were developments, such the important one in immunotherapy, "with the approval of nivolumab".

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