Alecensa Now FDA-Approved for Early-Stage ALK+ NSCLC

Earlier this year, the Patient Worthy team spoke with Dr. Ken Culver, the Director of Research & Clinical Affairs for ALK Positive, Inc., about Alecensa (alectinib). The therapy, said Dr. Culver, had the potential to be transformative for people living with ALK-positive non-small cell lung cancer (ALK+ NSCLC). Approximately 40% of people with ALK+ NSCLC are diagnosed in early stages. Unfortunately, many of them experience recurrence as chemotherapy is not effective. In sharing insights on clinical data, Dr. Culver explained that Alecensa improved disease-free survival and greatly reduced the risk of recurrence.

The US Food and Drug Administration (FDA) seems to agree that Alecensa has benefits for patients. In fact, reports Tristan Manalac, the FDA just approved Alecensa for the adjuvant treatment of individuals living with early-stage ALK+ NSCLC who have undergone tumor resection. Adjuvant therapy (or adjunct therapy) is given in addition to the primary therapy (such as chemotherapy or radiation) to improve how effective the medication works. Tumor resection means removing the tumor (or as much of the tumor as possible). Alecensa was approved as an adjunct therapy for people who have undergone surgery to remove their tumor.

Data from the Phase 3 ALINA study played a crucial role in this approval. You can learn more about those results by checking out the above interview with Dr. Culver. Outside of approval for this indication, Alecensa is also approved for people with metastatic ALK+ NSCLC who cannot use crizotinib, or for whom crizotinib has been ineffective, as well as metastatic ALK+ NSCLC more generally. This most recent approval means that even more patients will now have access to treatment.

What to Know About ALK+ NSCLC

Non-small cell lung cancer comprises around 80-85% of all lung cancer cases. In a smaller subset of NSCLC patients – about 3-5% – their cancer is caused by a rearrangement of the EML4 and ALK genes, which leads to the formation of a new EML4-ALK oncogene. This leads to the development of anaplastic lymphoma kinase (ALK)-positive NSCLC.

Some facets of ALK+ NSCLC make this cancer unique. First, 30% of patients with ALK+ NSCLC are diagnosed under 40 years old, with 50% diagnosed under 50 years old. Considering the average age of lung cancer diagnoses sits around 70 years old, ALK+ NSCLC overwhelmingly affects younger individuals. Further, it’s uncommon for people with ALK+ NSCLC to be smokers.

Symptoms of ALK+ NSCLC can include:

• Unintentional weight loss
• Chest pain that gets worse when you laugh or breathe
• Fatigue and general malaise
• Shortness of breath
• A persistant cough that may produce blood
• Wheezing
• Appetite loss
• A hoarse voice

Learn more about ALK+ NSCLC through ALK Positive.

ALK-positive non-small cell lung cancer ALK+ NSCLC cancer treatment drug approval lung cancer non-small cell lung cancer NSCLC treatment

Last modified: April 26, 2024