“Doctors are hailing ‘off the chart’ trial results that show a new drug stopped lung cancer advancing for longer than any other treatment in medical history,” reports The Guardian:
More than half of patients (60%) diagnosed with advanced forms of lung cancer who took lorlatinib were still alive five years later with no progression in their disease, data presented at the world’s largest cancer conference showed. The rate was 8% in patients treated with a standard drug, the trial found.
The results are the longest progression-free survival (PFS) outcomes ever recorded in patients with non-small cell lung cancer, the world’s most common form of the disease.
This matters because 1.8 million people die of lung cancer every year, more than any other type of cancer. Few people survive when they are afflicted by advanced forms of lung cancer, where the cancer has spread.
In the phase 3 trial, 296 patients with advanced forms of non-small cell lung cancer were randomly assigned to receive either lorlatinib or a standard drug. In a quarter of them, their lung cancer had already spread to the brain when the study began.
The patients in the trial all had ALK-positive non-small cell lung cancer. Lorlatinib and the standard drug are both ALK tyrosine kinase inhibitors (TKIs). They bind themselves to the ALK protein found in ALK-positive non-small cell lung cancer and thus stop the growth of cancer cells.
“Lorlatinib is the only ALK TKI that has reported five-year progression-free survival, and even after this time, the majority of patients continue to have their disease controlled, including control of disease in the brain,” says Dr. Benjamin Solomon.
This drug will not immediately save lives. Before it can be sold to the public, it first has to be approved by drug regulators like the FDA. That will take months or years, during which time, thousands or millions of people will die of lung cancer. “Following successful completion of a Phase 3 trial, a New Drug Application (NDA) can be submitted to the FDA to request review for approval. The FDA will then take 6-10 months to review all of the data submitted,” according to a fairly rosy assessment of the FDA’s approval process.
Many people die waiting for the FDA to approve life-saving drugs. For example, at least a hundred thousand people died waiting years for the FDA to approve beta blockers. One of the FDA officials involved in delaying their approval was John Nestor. Nestor was notorious for following rules in ways designed to deliberately delay other people, such as his habit of deliberately driving slowly in the fast lane on highways in order to slow down other motorists.
The FDA didn’t approve a home test for HIV until 24 years after it first received an application. According to an FDA advisory committee, the test held “the potential to prevent the transmission of more than 4,000 new HIV infections in its first year of use alone.” That means thousands of people likely got infected with AIDS as a result of the delay in approving it. As Roger Parloff noted in Fortune, the FDA’s delay in approving the home HIV test was a “scandal.” It caused the deaths of thousands of people.
