Regulatory Daily Summary: What Happened on October 8, 2026

Tukysa adds a maintenance option after initial breast cancer treatment

The FDA approved Tukysa with pertuzumab and trastuzumab for adults with unresectable, locally advanced or metastatic HER2-positive breast cancer that has not progressed after induction treatment.1 The regimen adds an oral tyrosine kinase inhibitor to maintenance treatment without chemotherapy during that phase, after patients have received taxane-based induction chemotherapy.16

In the Phase 3 HER2CLIMB-05 trial, median progression-free survival was 24.9 months with Tukysa and 16.3 months with placebo, both given with the two antibodies.16 Tukysa reduced the risk of disease progression or death by 35.9%. The trial has not shown that its overall-survival endpoint was met.16

Serious liver toxicity affected 3.9% of patients, including one fatal drug-induced liver injury.16 The prescribing information requires liver-function tests before and during treatment and carries a boxed warning for severe liver toxicity.6

PhRMA asks court to block Medicare’s GLOBE model

PhRMA sued the Trump administration over GLOBE, a Medicare Part B model that uses international prices to set an alternative rebate formula for some separately payable drugs and biologics.23 The trade group asked the court to declare the model unlawful and set it aside.3

PhRMA argues that the Centers for Medicare & Medicaid Services exceeded its authority by using a demonstration model to set prices nationwide without congressional approval.3 The group also argues that mandatory rebates do not genuinely test a new model and that GLOBE conflicts with Medicare’s rebate framework.3

GLOBE is scheduled to run from January 1, 2027, through March 31, 2032, in randomly selected areas covering about 25% of Original Medicare enrollees.3 Most companies were exempted after agreeing to voluntary pricing deals, leaving only a small number expected to face the pilot, according to reporting on the lawsuit.7

WHO puts lifestyle programs first in new pediatric obesity guidance

WHO’s first global guidelines on obesity care for children and adolescents recommend programs that address diet, physical activity and behavior, alone or in combination.4 The guidelines say supervised digital health support may also help.4

WHO does not recommend weight-loss medicines, devices or bariatric surgery for children 9 and younger.4 For adolescents, approved medicines may be considered if a supervised, multi-part lifestyle program has not achieved the intended result. Surgery remains an option for severe obesity.4

Obesity prevalence among people ages 5 to 19 has quadrupled since 1990. In 2024, 170 million people in that age group had obesity.4

Pharmaceutical import tariff takes effect amid questions about exemptions

A 100% Section 232 tariff on imported patented drugs and their active ingredients began applying at the end of September.5 The White House outlined ways to reduce tariff costs, including pricing agreements tied to prices in other wealthy countries or commitments to move production to the United States.5

Some biopharma companies and their industry group said they lacked clear instructions for obtaining exemptions.5 Most-favored-nation agreements exempt many large U.S. drugmakers, while smaller biotech companies remain exposed to the tariffs.5 Companies with those agreements were initially due to begin paying in July, but their payment obligations are deferred until early 2029.5

Also published

• Pharmaceutical Executive Daily: FDA Approves Tukysa Plus Trastuzumab and Pertuzumab Pharmaceutical Executive