The Bonnie J. Addario Lung Cancer Foundation (ALCF) applauds the medical research community and the U.S. Food and Drug Administration (FDA) for putting a heightened focus on lung cancer diagnostics and treatments. ALCF works everyday to educate patients and their families on the latest advancements, encourage participation in clinical trials and fund life-saving research on unmet medical needs to make these advances possible.
In 2015, the FDA approved seven new treatments for lung cancer patients, with five of these in the past two months. FDA programs such as the Breakthrough Therapy designation, Accelerated Approval, Priority Review and the Fast Track designation have allowed the expedited approval of life-saving lung cancer medicines that address unmet medical needs and provide clinical benefit to patients.
“Lung cancer patients can now count on having a plan B in their back pocket when plan A stops working. The ALCF thanks the FDA for this foresight and getting these critical medications to lung cancer patients expeditiously, saving lives now,” said Bonnie Addario, 11-year lung cancer survivor and founder of the ALCF. “New approvals give patients new hope that they will live longer lives. The ALCF also thanks all patients who participate in clinical trials, making all these exciting advances possible.”
The FDA approved Nivolumab (Opdivo), the first immunotherapy drug targeting lung cancer on March 4, 2015 — three months ahead of schedule — to treat squamous non-small cell lung cancer (NSCLC). In July 2015, the FDA approved Gefitinib (Iressa) to treat patients with metastatic NSCLC whose tumors had mutations in EGFR. Within the past two months alone, five additional treatments are available to lung cancer patients.
- Pembrolizumab (Keytruda), for patients with advanced, metastatic NSCLC whose disease has progressed after other treatments (chemotherapy or targeted therapy) and whose tumors express the protein PDL1
- Nivolumab (Opdivo), for the treatment of both squamous and non-squamous NSCLC
- Osimertinib (Tagrisso), for patients whose disease has progressed on EGFR-targeted therapies
- Necitumumab (portrazza), for the treatment of advanced, metastatic squamous NSCLC patients who have not been previously treated for their advanced lung cancer
- Alectinib (Alecensa), for patients with ALK (Anaplastic Lymphoma Kinase)-rearranged metastatic NSCLC who have progressed on or are intolerant to crizotinib (Xalkori)
“In 1971 President Richard Nixon declared war on cancer, but we are just starting the war on lung cancer,” said Addario. “Advancements during the past year have been game changing. Genomic profiling makes it possible to target and treat specific cancer mutations. Immunotherapy completely upends traditional treatment options using medicines to boost a patient’s own immune system to fight their disease. Many of us have a second chance because of the doctors, scientists and medical researchers working on our behalf, providing new medicines and treatment options.”
The timely approval and availability of these therapies allow more families to think of lung cancer survival in terms of years, not just months, and provide hope to make lung cancer a chronically manageable disease by 2023.
Lung cancer is the top cancer killer of men and women, killing almost twice as many women as any other cancers. It accounts for 27 percent of all cancer deaths and is the second leading cause of all deaths in the U.S. Last year an estimated 4,500 people under age 45 received a lung cancer diagnosis.