Alectinib, a new 2nd generation lung cancer treatment, approved by FDA


The FDA ( Food and Drug Administration ) has approved a new second-generation lung cancer treatment that can help many patients in their battle against the disease. Lung cancer patients got another round of hope with the FDA's rapid progression of lung cancer drug approvals - this time for Alectinib ( Alecensa ) for patients with advanced ( metastatic ) ALK-positive non-small cell lung cancer ( NSCLC ) if their disease deteriorated after treatment with another therapy called Crizotinib ( Xalkori ). Patients who could not tolerate treatment with Crizotinib also qualify for use of Alectinib.

Lung cancer is the leading cause of cancer deaths around the world, responsible for claiming more lives than prostate, colon and breast cancer combined. Medications that target the individual characteristics of a patient's disease continue to create new options and hope for those with lung cancer.
For example, tumor cells in about 5% of lung cancer patients with NSCLC contain the ALK ( anaplastic lymphoma kinase ) genetic mutation.
In patients with metastatic cancer, the disease spreads to new part of the body. For ALK-positive NSCLC metastatic patients, the disease often spreads to the brain.

Many ALK-positive patients benefit from treatments called ALK inhibitors, such as Crizotinib which blocks the activity of the ALK protein and can prevent NSCLC cells from growing and spreading. Alectinib is an oral medication that performs similarly.
Patients can also develop resistance to ALK inhibitors such as Crizotinib, so Alectinib gives health professionals a new option to continue to extend their patients' life span.

The FDA previously approved Ceritinib ( Zykadia ) in the same treatment setting.

Alectinib is the fifth lung cancer treatment approved by the FDA since early October. The others include:

a) Necitumumab ( Portrazza ), an anti-EGFR antibody, in combination with standard chemotherapy to treat patients with advanced squamous NSCLC who did not previously received systemic therapy;

b) Two immunotherapy treatments: Nivolumab ( Opdivo ) and Pembrolizumab ( Keytruda );

c) Osimertinib ( Tagrisso ), a 3rd-generation EGFR tyrosine kinase inhibitor ( TKI ). ( Xagena )

Source: International Association for the Study of Lung Cancer ( IASLC ), 2015

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