ICYMI: With the FDA’s Third Approval for Tissue Agnostic Therapies, Oncologists are Headed to the Next Level in Cancer Treatment

Since the 1940s oncologists have been focusing on tumors at the location in the body where the tumors originated. According to a recent FDA press release, this is the third time the FDA has granted accelerated approval to a drug with an entirely different agenda. These three newly approved drugs have the potential to transform cancer treatment.

The third newly approved treatment, Rozlytrek (entrectinib), is based on a measurable substance (biomarker) across all solid tumors with specific molecular alterations rather than at the location where the disease originated.

It is suggested that the only method of identifying people eligible for Rozlytrek therapy is through biomarker testing for NTRK fusion-positive tumors and ROS1 in NSCLC (non-small cell lung cancer).

Rozlytrek is one of many new drugs that target mutations. In this case, the mutations are key genetic drivers. The key drivers allow the cancer to invade the human body. Although there are several genetic mutations in cancer cells, only a few can be considered “drivers.”

About Rozlytreki

Rozlytrek was granted FDA approval for treating patients with ROS1-positive metastatic (had spread) non-small cell lung cancer (NSCLC). It is the number one cause of cancer deaths in the world. Over one and one half million people (4000 each day) lose their lives to NSCLC every year.

NSCLC accounts for eighty-five percent of all lung cancers diagnosed.

Additionally, FDA approval was granted for adolescent and adult patients who harbor the NTRK (neurotrophic tyrosine receptor kinase) gene fusion.

Both approvals were the result of pooled data provided by four clinical trials. Information about the clinical trials may be found here.

Information about common side effects during treatment with Rozlytrek is available here.

Rozlytrek was also granted Breakthrough Therapy, Orphan Drug, and Priority Review designations. These approvals were based on the integrated analysis that consisted of data on:

  • fifty-one patients with ROS1- positive NSCLC, and
  • Fifty-four patients with advanced or metastatic NTRK gene fusions

Rozlytrek shrank 78% of NSCLC tumors and shrank tumors in more than half NTRK patients.

The FDA’s Commitment

The FDA has demonstrated its support by reviewing the performance of these drugs through its expanded pathways. The FDA’s granting of accelerated approval requires the sponsor, in this case, Genentech, Inc., to submit additional data.


Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia four years ago. He was treated with a methylating agent While he was being treated with a hypomethylating agent, Rose researched investigational drugs being developed to treat relapsed/refractory AML.

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