FDA Approves Gilotrif to Treat Patients with Metastatic NSCLC

Boehringer Ingelheim Approval:

Boehringer Ingelheim reported that the US Food and Drug Administration (FDA) have approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients with EGFR mutation-positive non- small cell lung cancer (NSCLC). Which implies that Individuals tumors have non- resistant epidermal growth factor receptor (EGFR) mutations as detected by a FDA approved test.

The new label includes information on three additional EGFR mutations: L861Q, G719X, and S768I. The FDA agreed with Priority Review status to Gilotrif in assessing this application.

FDA Approves Gilotrif to Treat Patients with Metastatic NSCLC

Indications and Usage of Gilotrif (afatinib):

Gilotrif, is an oral, once-everyday tablet, for the “first-line” treatment of NSCLC patients. Patients tumors have (EGFR) exon 19 deletions or exon 21 L858R mutations which was previously approved in the U.S.

Additionally, Gilotrif is approved in the U.S. for patients with squamous cell carcinoma of the lung whose disease has advanced after treatment with platinum-based chemotherapy.

Sabine Luik, M.D., senior vice president of medicine & regulatory affairs, Boehringer Ingelheim Pharmaceuticals, Inc said, “With this expanded sign for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved treatment that particularly targets on these mutations”.

“This approval is an outcome of our company’s commitment of duty regarding delivering meaningful treatment advances in zones with high unmet medical need and reflects the tireless efforts of doctors, scientists, and patients who participated in our examinations.”

Supplemental New Drug Application:

The sNDA approval is based on a pooled analysis of three studies from the LUX-Lung clinical trial program (phase II LUX-Lung 2 study and phase III studies LUX-Lung 3 and LUX-Lung 6) that analyzed Gilotrif in NSCLC patients whose tumors have EGFR mutations, including L861Q, G719X or S768I.

This study demonstrated that Gilotrif was active in these EGFR mutations in view of objective response rate, duration of response, disease control, progression-free survival and overall survival.

Edward Kim, M.D., Levine Cancer Institute, Carolinas HealthCare System said, “Compared with other EGFR mutations, L861Q, G719X or S768I substitution mutations are related with a poorer prognosis and limited treatment options”.

“The approval of Gilotrif as a targeted on treatment for these additional non- resistant EGFR mutations essentially changes the treatment strategy for this populace.”

Limitation of Use:

To determine whether a patient is eligible for Gilotrif, doctors must lead a test for genetic mutations – otherwise called biomarker testing to determine the type of EGFR mutation present.

Laurie Fenton Ambrose, president and CEO of Lung Cancer Alliance said, “This approval is more welcome news for our lung cancer community”.

“These types of advances are helping expand to treatment options for patients who may benefit from targeted treatments to fight their particular type of lung cancer.”

Gilotrif is used in the treatment of patients with non-small cell lung cancer (NSCLC) that has certain (non- resistant) abnormal epidermal growth factor receptor (EGFR) gene(s).

Healthcare Professional Performs A Test:

Your healthcare provider will perform a test to ensure that Gilotrif is appropriate for you; has spread to other parts of the body (metastatic), and has not been previously treated for metastatic lung cancer previously treated for metastatic lung cancer.

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