Editor’s Briefing: October 15, 2026

In Short. America’s drug regulator approved a wider use of ImmunityBio’s bladder-cancer drug by borrowing evidence from a related form of the disease. Arrowhead reported that an injection under the skin cut a brain protein linked to Alzheimer’s disease in healthy volunteers.

The FDA uses one bladder-cancer trial to approve a drug for a second form of the disease

THE FOOD AND DRUG ADMINISTRATION (FDA), America’s drug regulator, on Wednesday expanded the approval of Anktiva, an immune-boosting drug from ImmunityBio given into the bladder with BCG, a weakened bacterium long used to treat early bladder cancer. The new use covers adults whose high-grade papillary tumors, growths that stick out from the bladder lining without invading its muscle, have stopped responding to BCG. Anktiva is the first drug approved specifically for them. The agency did not rely on a new trial for this group. It pointed instead to the study behind Anktiva’s 2024 approval for carcinoma in situ, a flat form of early bladder cancer, in which 62% of 77 patients had no detectable high-grade cancer after treatment. It argued that the two forms often occur together, look alike under a microscope and behave similarly once BCG fails. The FDA called this a new approach and said it is finishing guidance that will allow such borrowing for other drugs. The decision came nearly three months before the agency’s deadline, according to Fierce Pharma.

Arrowhead’s gene-silencing drug reaches the brain from under the skin

ARROWHEAD PHARMACEUTICALS reported on Wednesday interim results for ARO-MAPT, a small interfering RNA (siRNA), a short strand of genetic material that switches off a chosen gene. Its target is the gene for tau, a protein that clumps inside nerve cells in Alzheimer’s disease and several rarer dementias. Most siRNA drugs work only in the liver, and getting them into the brain has usually meant injecting them into the spinal fluid. In healthy volunteers given ARO-MAPT under the skin, tau in the spinal fluid fell by a mean of 40%, 69% and 73% from baseline across three rising doses, measured 90 days after the last dose. No serious side effects were reported. The results come from people without disease, and Arrowhead noted that effects on tau tangles, memory and decline must still be tested in patients, who are now being enrolled.

Verastem reports early results for its pancreatic-cancer drug

VERASTEM ONCOLOGY on Wednesday released early data from a first trial of VS-7375. The drug blocks a mutated form of KRAS, a protein that drives cell growth. Among 22 evaluable patients with pancreatic cancer that had spread, 67% were alive without their cancer worsening after six months, according to Fierce Biotech. Tumors shrank in between 36% and 50% of pancreatic patients, depending on how many earlier treatments they had received, and in 43% of 23 patients with lung cancer. The trial had no comparison group. Verastem said it plans to start a late-stage trial in pancreatic cancer by the end of the year, with trials in bowel and lung cancer to follow in the first half of 2027.

Adlai Nortye pairs its targeted cancer drug with an older antibody

ADLAI NORTYE said on Thursday morning that it had signed agreements with Eli Lilly and Merck KGaA, a German drugmaker, to supply cetuximab for an early trial. Cetuximab is an antibody that blocks EGFR, a receptor that tells cells to grow. Adlai Nortye’s drug, AN4035, is an antibody-drug conjugate, an antibody that carries a toxic payload to cells bearing a chosen marker. Here the marker is CEACAM5, common on bowel, pancreatic and lung tumors, and the payload blocks the active form of RAS proteins. The firm said that delivering the RAS blocker this way may limit the side effects that have made it hard to combine such drugs with EGFR blockers. The trial, which Adlai Nortye runs at sites in America, Australia and China, will test AN4035 alone and with cetuximab.