Remarkable Cancer Drugs Come With Fatal Side Effect For Some, And Researchers Don’t Know Why
The class of drugs known as checkpoint inhibitors causes an inflammation of the heart muscles. As the use of the drugs expands, researchers are sure that more people will develop deadly heart conditions. In other pharmaceutical news: FDA approval for rare drugs; lung cancer treatments; lawsuits over antipsychotic drug side effects; and right-to-try legislation.
As Checkpoint Inhibitors Spread, So Does Risk Of Deadly Heart Condition
Clinicians have seen remarkable progress in cancer patients treated with the class of immunotherapy drugs known as checkpoint inhibitors. In a small number of patients, they have also seen a rare but fatal cardiovascular side effect known as myocarditis. Now, with checkpoint inhibitors likely to be approved for a wider array of cancers, researchers are concerned that it’s only a matter of time before more patients develop the same autoimmune response. They still don’t know why. (Keshavan, 3/20)
FDA, Industry Ponder Changes To Clinical Trials For Rare Disease Treatments
Food and Drug Administration statisticians pondered changing how the agency uses statistics to approve drugs for rare disease at a public workshop Monday. The challenge, regulators said, is that there are so few patients who suffer from certain rare diseases that it might not be possible or feasible to do many rounds of traditional clinical trials. So, regulators and drug developers are looking at ways to import data collected in early studies — which are used to initially assess drug safety and efficacy — into the Phase 3 studies that the FDA uses to determine whether drugs should make it onto the market. (Swetlitz, 3/19)
Roche Says Tecentriq, Chemo Cut Risk Of Death In Type Of Lung Cancer
Roche's immunotherapy Tecentriq plus chemotherapy cut the risk of disease worsening or death in advanced squamous lung cancer, but it did not yet show an overall survival benefit in this tough-to-treat disease, the Swiss drugmaker said Tuesday. A late-stage study, called IMpower131, demonstrated that Tecentriq combined with carboplatin and Abraxane boosted progression-free survival (PFS), compared with chemotherapy alone, in patients getting initial treatment. (Miller, 3/20)
Bristol-Myers, Otsuka Face Trial Over Antipsychotic And Compulsive Behavior
The first of hundreds of lawsuits filed by consumers who claim the Abilify antipsychotic caused compulsive behavior has been scheduled for trial in June after a federal judge tossed a bid by drug makers to dismiss the litigation. The bellwether trial would be the first to put a sustained spotlight on the extent to which the widely used medication has caused patients to succumb to uncontrollable urges to engage in impulsive gambling, shopping, eating, or sex. About 700 lawsuits have been filed in federal court in Florida and dozens more were filed in other states, mostly in New Jersey. (Silverman, 3/19)
Former FDA Heads Speak Out Against 'Right To Try'
Four former heads of the Food and Drug Administration (FDA) are urging Congress to abandon bills that would allow terminally ill patients access to experimental drugs not yet approved by the agency. The "right to try" bill failed in the House last week, but is likely to come up again this week. A similar bill passed the Senate last summer. (Hellmann, 3/19)