Health Headlines: Breakthroughs, Challenges, and Risks

Current health news highlights include Gilead’s Trodelvy extending lung cancer survival by 1.3 months, Pfizer’s Lorbrena showing promising 5-year data, FDA staff raising concerns on MDMA-assisted PTSD treatment, and more. Key stories cover medical advancements, regulatory updates, and public health risks.

Following is a summary of current health news briefs.

Gilead's Trodelvy extends lung cancer survival by just 1.3 months in trial

Gilead Sciences' Trodelvy improved survival by 1.3 months more than chemotherapy in previously treated patients with advanced lung cancer in a late-stage trial, a difference that was not statistically significant, the company said on Friday. Patients given Trodelvy lived for a median of 11.1 months, while those on chemotherapy lived for 9.8 months, Gilead said. The company in January said that the non-small cell lung cancer (NSCLC) trial had failed to meet its main goal of proving Trodelvy could extend survival over chemotherapy.

Pfizer sees lung cancer drug topping $1 billion in sales following impressive 5-year data

Pfizer said it expects its cancer drug Lorbrena to top $1 billion in annual sales by 2030 on the strength of data presented on Friday showing most patients treated for a rare form of advanced lung cancer in a clinical trial were alive without the disease worsening after five years. Lorbrena, like Pfizer's Xalkori, is designed to treat cancer with a mutation of a specific gene called anaplastic lymphoma kinase, or ALK.

US FDA staff flags concerns on MDMA-assisted PTSD treatment

The U.S. health regulator's staff reviewers on Friday raised concerns related to interpretation of results from trials for Lykos Therapeutics' psychedelic drug MDMA to treat post-traumatic stress disorder. A panel of outside advisers to the U.S. Food and Drug Administration will meet on Tuesday to review for the first time a form of MDMA.

EU regulator backs use of Pfizer's gene therapy for rare bleeding disorder

The European Medicines Agency (EMA) has recommended the use of Pfizer's gene therapy for a rare bleeding disorder called hemophilia B, which typically requires regular infusions of a blood-clotting protein, the regulator said on Friday. The regulator has recommended granting a 'conditional marketing authorization,' which is for the approval of a medicine addressing unmet medical needs of patients based on less comprehensive data than normally required.

EU regulator recommends use of Valneva's chikungunya vaccine

The European Medicines Agency (EMA) recommended the use of Valneva's single-shot vaccine for chikungunya virus, the regulator said on Friday. With an approval from the European Commission following this recommendation, the French vaccine maker's VLA1553 will be the first preventive shot to be approved in Europe for adults suffering from the mosquito-borne disease.

Waterborne illness now threaten flood-ravaged southern Brazil

Waterborne diseases are now a risk in Brazil's southernmost state, authorities say, as residents begin to return to flooded homes and clean up after catastrophic floods that killed at least 169 people. Rains that started in late April swelled several rivers and lakes in Rio Grande do Sul state to record highs and more than 580,000 people were driven from their homes by the flooding, according to state officials.

EMA backs approving Sanofi's Dupixent for 'smoker's lungs', FDA extends review

Sanofi and partner Regeneron Pharmaceuticals have secured the European regulator's backing for use of Dupixent in patients with a chronic lung disease even as the U.S. Food and Drug Administration (FDA) extended its review. French drugmaker Sanofi and its U.S. partner have been counting on expanding the use of the drug as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD) - also called 'smoker's lungs' as the lifelong condition commonly affects cigarette smokers.

Bird flu infects third US dairy worker; Michigan set to expand testing

A third U.S. dairy worker tested positive for bird flu after exposure to infected cows, and was the first to suffer respiratory problems, U.S. officials said on Thursday. The infection was the second human case in Michigan, which has confirmed more cases of bird flu in dairy cattle than any other state. It also expands the symptoms for human cases, after the two workers who previously tested positive experienced only conjunctivitis, or pink eye, and recovered.

Novartis leukemia drug more effective than older treatments in trial

Swiss drugmaker Novartis said patients with a type of leukemia who took its Scemblix had a significantly better response and a lower dropout rate than those who received current standard-of-care drugs in a late-stage study with details presented on Friday. The company said in January that the oral drug met the main goals of the 405-patient trial.

World unprepared for another pandemic as WHO treaty talks push on

The world is unprepared for another health crisis like COVID-19, a leading global health expert has warned, as countries make a last push to agree a way forward for a pandemic treaty amid fears the political climate for agreement could sour. World Health Organization member states gathered in Geneva on Friday to work out how to continue negotiations about an accord after missing this month’s deadline.