FDA Approves Lorlatinib to Treat Some Lung Cancer
- The FDA approved lorlatinib to treat metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) this month, offering a new option to some lung cancer patients.
- ALK-positive NSCLC makes up about 5% of NSCLC cases.
- For those with ALK-positive NSCLC, doctors say lorlatinib has proven promising, particularly those with brain metastases.
About ALK-Positive NSCLC
Overall, lung cancer is the second most common form of cancer in the United States. It's also the most deadly. NSCLC makes up about 85 percent of all cancer cases, and about 5 percent of those cases are ALK-positive.
Read MoreWhat the Approval of Lorlatinib Means for Lung Cancer Patients
SurvivorNet spoke with Dr. Karen L. Reckamp, director, Division of Medical Oncology, and associate director, Clinical Research at Cedars-Sinai, who said while the drug is approved for the treatment of a very small portion of lung cancer patients, the efficacy is very high and the tumor shrinkage is very good with lorlatinib.
Lorlatinib is now one of five drugs that are approved for ALK NSCLC. She said one of its benefits is that it has excellent penetration into the brain, and brain metastases are common in NSCLC. (This means the cancer has spread to the brain.) It also covers some of what are called "resistance mutations" that can occur with some of the other drugs that are in this class.
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"So it’s a positive outcome for patients with ALK NSCLC, but it's not applicable for all patients with lung cancer," Reckamp told SurvivorNet. "It’s for a subset of non-small-cell lung cancer, it’s not for all non-small-cell lung cancer. It’s very good for patients to have options, and so it’s a positive thing for patients with ALK-positive lung cancer.”
Dr. Joshua Sabari, a medical oncologist at NYU Langone's Perlmutter Cancer Center and assistant professor of medicine at NYU Grossman School of Medicine, told SurvivorNet that lorlatinib previously received accelerated approval in the second- or third-line setting in patients with ALK NSCLC. This recent approval expands on this indication, including the first-line treatment setting of these patients and confirms the full approval of this agent in the later-line setting.
"The approval is based on the impressive data presented in the phase III CROWN study, which demonstrated a significant improvement in progression-free survival as well as overall survival when lorlatinib was compared to crizotinib, particularly in patients with intracranial metastases," Sabari said. "Alectinib remains the standard of care in the front line setting, however, the full approval of lorlatinib adds another therapeutic option to our armamentarium in ALK-rearranged NSCLC."
Side Effects of Lorlatinib
According the FDA, side effects of lorlatinib may include the following:
- Edema
- Peripheral neuropathy
- Weight gain
- Cognitive effects
- Fatigue
- Dyspnea
- Arthralgia
- Diarrhea
- Mood effects
- Hypercholesterolemia
- Hypertriglyceridemia
- Cough
For more information about lorlatinib and to determine if it might be an effective part of your treatment plan, consult your health care provider.
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