Atezolizumab, ibogaine, and GlaxoSmithKline: the issue of October 5, 2026

The week of October 5 to 11, 2026 on The Priority Review: 44 briefs and 9 stories, led by atezolizumab, ibogaine, and GlaxoSmithKline. Every line links its page.

Stories this week

• CMS publishes 2027 Medicare Advantage and Part D Star Ratings (written story)
• FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer (written story)
• FDA approves Hovilpri for immunocompromised adults with unresponsive HSV lesions (written story)
• FDA approves tucatinib with trastuzumab and pertuzumab for HER2-positive breast cancer (written story)
• Janssen posts results of long-term aticaprant study in 871 participants (written story)
• Sanofi posts results of Phase 3 MenACYW conjugate vaccine study in infants (written story)
• FDA actions, week of October 5, 2026: 3 approvals, 5 rules, 7 notices, 1 announcement (weekly data page)
• New Phase 3 trials registered, week of October 5, 2026: 11 industry trials (weekly data page)
• Phase 3 results posted, week of October 5, 2026: 12 industry trials (weekly data page)

Terms this week

• mucocutaneous lesions – sores that occur on skin or mucosal surfaces, such as lips, nostrils, eyes and genitals. The FDA uses this term to describe where herpes simplex virus infection shows up. (FDA: FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus)

Approvals briefs

• FDA approves Hovilpri for immunocompromised patients with HSV lesions. The FDA approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus and have not responded to acyclovir, valacyclovir, or famciclovir. In a Phase 3 trial, 63% of patients treated with Hovilpri had all lesions healed by 28 days versus 34% with other medications. Source: FDA approval page, October 9, 2026.
• FDA approves atezolizumab with chemotherapy for Stage III dMMR colon cancer. On October 8, 2026, the FDA approved atezolizumab (Tecentriq, Genentech, Inc.) with fluoropyrimidine and oxaliplatin for adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient colon cancer. The approval also covers atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for patients 12 years and older who weigh 40 kg or greater. Source: FDA approval page, October 8, 2026.
• FDA approves tucatinib with trastuzumab and pertuzumab for HER2-positive breast cancer maintenance. On October 7, 2026, the FDA approved tucatinib (Tukysa, Seagen Inc., a subsidiary of Pfizer) in combination with trastuzumab and pertuzumab for adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment. The approval follows a randomized, double-blind, placebo-controlled trial of 654 patients that showed a median progression-free survival of 24.9 months versus 16.3 months in the placebo arm. Source: FDA approval page, October 7, 2026.

Clinical trials briefs

• BioMarin presents new VOXZOGO data at ASBMR 2026. BioMarin will present new data from 13 studies, including a randomized, double-blind, placebo-controlled trial on VOXZOGO's effect on foramen magnum and craniocervical junction growth in children with achondroplasia. The company will also share data on the investigational long-acting medicine BMN 333 and on VOXZOGO's potential use in hypochondroplasia, for which it has submitted a supplemental New Drug Application. Source: Source record, October 9, 2026.
• Sanofi posts results of Phase 3 Itepekimab trial in COPD. The study, NCT04751487 (AERIFY-2), enrolled 1234 participants and completed in April 2025. It evaluated itepekimab versus placebo on exacerbation rates, pulmonary function, and safety in moderate-to-severe COPD patients. Source: Source record, October 9, 2026.
• Hoffmann-La Roche posts results of Phase 3 alectinib rollover study. Results for the study were first posted on ClinicalTrials.gov on October 9, 2026. The completed Phase 3 rollover study enrolled 50 participants and compared alectinib with crizotinib in patients with ALK- or RET-positive cancer. Source: Source record, October 9, 2026.
• Hoffmann-La Roche posts results of Phase 3 IMpower030 atezolizumab trial in resectable NSCLC. Results for the IMpower030 study were first posted on ClinicalTrials.gov on October 9, 2026. The Phase 3 trial enrolled 453 participants and completed primary data collection on October 1, 2025. Source: Source record, October 9, 2026.
• Viking Therapeutics registers Phase 3 trial of VK2735 for weight management in type 2 diabetes. The study plans to enroll 560 participants and is expected to begin on October 16, 2026. It plans to evaluate oral VK2735 for weight management in adults with type 2 diabetes who are obese or overweight. Source: Source record, October 9, 2026.
• FrieslandCampina registers Phase 3 trial of infant formula with bio-active ingredients. The study was first posted on ClinicalTrials.gov on October 9, 2026, and plans to enroll 387 participants with a start date of January 2027. It aims to compare growth, immune parameters, and gut health between infants receiving the investigational formula and those receiving a control formula. Source: Source record, October 9, 2026.

21 more briefs in Clinical trials.

Regulation briefs

• FDA issues priority review voucher for ZANVASTRO. FDA approved ZANVASTRO on September 3, 2026. FDA issued a priority review voucher to the sponsor, Ionis Pharmaceuticals, Inc., after determining the product meets the criteria under the FD&C Act. Source: Federal Register notice, October 9, 2026.
• FDA withdraws approval of 37 ANDAs. The agency is withdrawing approval of 37 abbreviated new drug applications from multiple applicants. The applicants notified the FDA that the drug products were no longer marketed and requested the approvals be withdrawn. Source: Federal Register notice, October 9, 2026.
• FDA withdraws approval of Amneal's celecoxib ANDA. FDA withdraws approval of abbreviated new drug application 208833 for celecoxib capsules 50 mg, 100 mg, 200 mg, and 400 mg held by Amneal Pharmaceuticals of New York, LLC. Amneal requested the withdrawal and waived its opportunity for a hearing. Source: Federal Register notice, October 9, 2026.
• FDA corrects withdrawal notice of 16 ANDAs. The FDA issued a correction to a June 3, 2026 notice that announced the withdrawal of approval of 16 abbreviated new drug applications, effective July 6, 2026. The correction removes entries for ANDA 207366, ANDA 212957, and ANDA 218638, noting that Navinta LLC requested the approvals not be withdrawn, so those approvals remain in effect. Source: Federal Register notice, October 9, 2026.
• FDA classifies infant pulse rate and oxygen saturation monitor as class II. The order assigns the device to class II, adding special controls to the codified language. The action is expected to enhance patients' access to beneficial innovative devices by reducing regulatory burdens. Source: Federal Register rule, October 9, 2026.
• FDA classifies hematopoietic cell enrichment kit as class II device. The order designates the kit as a class II device with special controls. The special controls will be part of the codified language for classification of the hematopoietic cell enrichment kit. Source: Federal Register rule, October 9, 2026.

7 more briefs in Regulation.

Policy briefs

• CMS releases 2027 Medicare Advantage and Part D Star Ratings. The Centers for Medicare & Medicaid Services published the 2027 Star Ratings on October 8, 2026, and the ratings will impact 2028 MA quality bonus payments. Approximately 37% of MA-PD contracts (188 contracts) earned four stars or higher, and 27% of PDPs (11 contracts) received four or more stars for 2027. Source: Source record, October 8, 2026.

How this issue is made

Code builds this page every Monday from the week's published briefs and stories, listed above. The three topics in the title are the names the briefs tag most often that week. No model writes this page.