Lilly, NSCLC, and Eli Lilly and Company: the issue of October 19, 2026

The week of October 19 to 25, 2026 on The Priority Review: 46 briefs and 15 stories, led by Lilly, NSCLC, and Eli Lilly and Company. Every line links its page.

Stories this week

• 0.8% of adults with HIV-1 had HIV-1 RNA ≥50 copies/mL at Week 48 on bictegravir/lenacapavir (written story)
• 14.8 vs 7.8 months median overall survival, brentuximab vedotin combination vs placebo, in DLBCL (written story)
• 64.0 percent had a pathological complete response on pembrolizumab, 54.7 percent on placebo, in TNBC (written story)
• CMS and states offer up to $50,000 for a three-year nursing-home commitment (written story)
• CMS proposes that Exchanges verify income, family size and residence before financial assistance (written story)
• FDA approves first generic of Climara Pro, a once-weekly estradiol and levonorgestrel patch (written story)
• FDA approves Hibsago for certain adults with chronic hepatitis B (written story)
• FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer (written story)
• FDA grants traditional approval for pembrolizumab in TMB-H tumors; 36% had an objective response (written story)
• Five of 10 October FDA approvals were new uses for cancer drugs the FDA had approved before (written story)
• Janssen posts Phase 3 ustekinumab results in pediatric ulcerative colitis (written story)
• Protagonist posts results of Phase 3 rusfertide study in polycythemia vera (written story)
• FDA actions, week of October 19, 2026: 5 approvals, 2 proposed rules, 2 notices, 1 announcement (weekly data page)
• New Phase 3 trials registered, week of October 19, 2026: 14 industry trials (weekly data page)
• Phase 3 results posted, week of October 19, 2026: 5 industry trials (weekly data page)

Terms this week

• polycythemia vera – a bone marrow disease that leads to an abnormal increase in the number of blood cells. The red blood cells are the most affected blood cell type. (MedlinePlus: Polycythemia vera)
• accelerated approval – an FDA pathway for drugs for serious conditions that fill an unmet medical need. Approval rests on a marker, such as a laboratory measurement or radiographic image, that is thought to predict clinical benefit but is not itself a measure of clinical benefit. (FDA: Accelerated Approval)
• ulcerative colitis – a chronic disease in which abnormal reactions of the immune system cause inflammation and ulcers on the inner lining of the large intestine. (National Institute of Diabetes and Digestive and Kidney Diseases: Definition & Facts of Ulcerative Colitis)
• accelerated approval – An FDA path for drugs for serious conditions that fill an unmet medical need, based on a measure thought to predict clinical benefit. The drug company still has to run studies to confirm that benefit. (FDA: Accelerated Approval)
• Functional cure – GSK defines this as HBV DNA and HBsAg remaining undetectable for at least 24 weeks after stopping all treatment. (GSK: Hibsago approved in the US)
• Stable baseline regimen – The antiretroviral treatment a participant was already taking when entering the comparison; in this study, the control group continued it during the 48-week randomized period. (trial record NCT05502341)
• progression-free survival – the time from the date of randomization to the date of first documentation of progressive disease or to death due to any cause, whichever occurred first, based on the investigator's assessment of tumor response. (ClinicalTrials.gov: Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL)
• Pathological complete response – after treatment given before surgery, a pathologist finds no invasive cancer in the removed breast tissue and the sampled lymph nodes. The record's main definition allows noninvasive residuals in the breast. (Merck Sharp & Dohme LLC study record NCT03036488: Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522))
• generic – a generic medicine is required to be the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken. (FDA: Generic Drug Facts)
• traditional approval – the approval the FDA grants for a drug when a confirmatory trial shows that the drug actually provides a clinical benefit. (FDA: Accelerated Approval Program)
• inconsistency period – the time when an Exchange cannot verify a consumer's information electronically. During it, the consumer needs to submit documentation to verify the information. (CMS: Exchange Pre-Eligibility Verification Proposed Rule (CMS 9873-P))
• Civil monetary penalties – Penalties that CMS and states collect from nursing homes. CMS says collections from these penalties fund Nurses for Nursing Homes. (CMS: CMS and States Launch $275 Million Initiative to Recruit and Retain Nurses in Nursing Homes)

Approvals briefs

• FDA approves first once-weekly insulin for type 2 diabetes in pediatric patients. Awiqli (insulin icodec-abae) is approved for children aged 10 years and older with type 2 diabetes mellitus. The drug is administered by subcutaneous injection once weekly and was approved after a priority review. Source: FDA approval page, October 23, 2026.
• FDA grants traditional approval for pembrolizumab and Keytruda QLEX for TMB-H solid tumors. On October 16, 2026 the FDA granted traditional approval to pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmh (Keytruda QLEX) for patients with unresectable or metastatic tumor mutational burden-high (TMB-H) solid tumors defined as ≥13 mutations/megabase. In the KEYNOTE-158 study, 220 patients with TMB ≥13 mut/Mb had an objective response rate of 36% (95% CI: 30, 43) and 58% achieved a duration of response of at least 12 months. Source: FDA approval page, October 22, 2026.
• FDA approves first-of-its-kind chronic hepatitis B treatment. The FDA approved Hibsago (bepirovirsen) injection for adults without cirrhosis who have been on antiviral therapy for at least six months and have HBsAg levels of 3,000 IU/mL or less. The approval includes the Roche Elecsys HBsAg II quant II RxDx assay as a companion diagnostic. Source: FDA press announcement, October 20, 2026.
• FDA approves once-weekly generic hormone therapy patch for women. The FDA approved the first generic of Climara Pro, a transdermal estradiol and levonorgestrel system (0.045 mg per day/0.015 mg) applied once a week for women with an intact uterus. The generic is therapeutically equivalent to Climara Pro and the most common adverse reactions are application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache and flu syndrome (≥5 %). Source: FDA press announcement, October 20, 2026.
• FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer. On October 19, 2026 the FDA granted accelerated approval to dostarlimab (Jemperli, GSK) for adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high or mismatch repair deficient. The approval was based on AZUR-1, a single-arm trial of 154 patients that reported a 47% sustained clinical complete response at 12 months per independent central review. Source: FDA approval page, October 19, 2026.

Clinical trials briefs

• Nivolumab plus ipilimumab shows significant OS benefit versus NIVO and chemotherapy. The authors reported a hazard ratio of 0.61 versus NIVO across all lines and 0.37 versus chemotherapy in first-line therapy, with 95% confidence intervals of 0.46-0.82 and 0.24-0.57 respectively. Grade 3/4 treatment-related adverse events occurred in 22% of NIVO+IPI patients versus 14% of NIVO patients, with no new safety concerns. Source: Source record, October 25, 2026.
• PRABITAS trial shows 14-day trifluridine-tipiracil plus bevacizumab non-inferior to 28-day schedule. The authors reported that the 14-day schedule achieved a median overall survival of 11·3 months versus 10·3 months for the 28-day schedule, with a stratified hazard ratio of 0·93 (95% CI 0·80-1·08). Neutropenia grade 3 or worse was reduced by 25 percentage points (13% vs 39%) and anorexia grade 2 or worse by 11 percentage points (15% vs 26%). Source: Source record, October 25, 2026.
• Johnson & Johnson reports 75% tumor response rate in advanced prostate cancer with JNJ-6143. Johnson & Johnson said that in a Phase 1 study of JNJ-6143, 75 percent (12 of 16) of patients with measurable disease achieved a confirmed complete or partial response. The company also noted that 77 percent of patients at the 50-mg dose had a confirmed PSA reduction of at least 50 percent, with 48 percent achieving reductions of at least 90 percent. Source: Source record, October 25, 2026.
• Lilly presents durable first-line activity of olomorasib in KRAS G12C-mutant NSCLC at ESMO 2026. Lilly reported that olomorasib plus pembrolizumab without chemotherapy achieved durable efficacy, with median progression-free survival not yet reached after a median follow-up of 20.7 months. In a separate rapid oral presentation, the combination with chemoimmunotherapy yielded a 62% investigator-assessed overall response rate and a median duration of response of 14.5 months. Source: Source record, October 25, 2026.
• Lilly reports 79% response rate for Sofe-M in platinum-sensitive ovarian cancer. The Phase 1 study of sofetabart mipitecan (Sofe-M) plus bevacizumab in 29 patients with measurable disease reported a confirmed objective response rate of 79.3% (23/29) and a disease control rate of 100%. The most common grade ≥3 adverse events were neutropenia (42%) and anemia (24%), with 6% of patients discontinuing treatment due to an adverse event. Source: Source record, October 24, 2026.
• Nivolumab plus relatlimab plus chemo vs nivolumab plus chemo in NSCLC. The authors reported that the primary endpoint of objective response rate was not met (51.3% versus 45.0%). In the PD-L1 ≥1% nonsquamous subgroup, a trend toward improved clinical benefit was seen (ORR 58.0% versus 39.6%; PFS HR 0.68). Source: Source record, October 23, 2026.

25 more briefs in Clinical trials.

Regulation briefs

• FDA corrects patent extension review periods for six drugs. The FDA corrects the length of the regulatory review period for ANDEMBRY, ANZUPGO, ANKTIVA, BIZENGRI, BRINSUPRI, and DAYVIGO due to calculation errors. The corrections apply to determinations announced on August 10, August 17, and September 9, 2026; no other changes are made. Source: Federal Register notice, October 23, 2026.
• FDA proposes action levels for cadmium in food for babies and young children. The FDA announced a draft guidance titled "Action Levels for Cadmium in Processed Food Intended for Babies and Young Children" that will establish action levels for cadmium in certain processed foods intended for babies and young children less than 2 years old. The draft guidance is intended to set achievable action levels that will help further reduce cadmium in the food supply. Source: Federal Register proposed rule, October 23, 2026.
• FDA releases draft chapter on chemical hazard control for human food. The FDA announced the availability of a new draft chapter, Chapter 12: Control of Chemical Hazards, as part of its multichapter draft guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food. The guidance is not final and is not yet in effect. Source: Federal Register proposed rule, October 23, 2026.
• AMA and EMA issue joint guidance on Ebola vaccine development. The EMA's Emergency Task Force and the African Medicines Agency released a joint position paper outlining minimum requirements for clinical trials of Bundibugyo virus vaccines, including guidance on when animal toxicity studies may be waived. The paper also recommends early trials in Africa, a single-dose vaccine preference, and a ring trial design for Phase III studies. Source: Source record, October 23, 2026.
• FDA issues final guidance on prescription drug apps and software. The FDA released final guidance on October 20, 2026 that clarifies when app content is subject to FDA submission requirements and when it should be mentioned on a drug's official label. The guidance identifies two categories of companion software-apps connected to a medical device and standalone apps-and sets conditions for labeling and what companies should submit to the agency. Source: FDA press announcement, October 20, 2026.
• FDA releases guidance on new dietary ingredient notifications. The Food and Drug Administration announced the availability of final guidance titled "New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI: Guidance for Industry." The guidance addresses frequently asked questions and provides recommendations for manufacturers and distributors on the identity and safety information that should be included in an NDIN. Source: Federal Register notice, October 20, 2026.

Policy briefs

• CMS proposes pre-eligibility verification rule for health exchanges. The rule would require exchanges to verify household income, family size, citizenship status and residence before providing financial assistance, with the first pre-Open-Enrollment verification window beginning August 1, 2027 for 2028 coverage. Stakeholders may submit comments during the 30-day period following publication. Source: Source record, October 23, 2026.
• UCB establishes Emmanuel Janssen Endowed Chair at Brigham and Women's Hospital. UCB announced the creation of a permanently endowed chair in pharmacoepidemiology and pharmacoeconomics at Brigham and Women's Hospital, naming Sebastian Schneeweiss, MD, ScD, as the inaugural incumbent. The chair is intended to advance real-world evidence research and improve how medicines are evaluated and used in clinical practice. Source: Source record, October 23, 2026.
• CMS launches $275 million initiative to recruit nurses in nursing homes. The initiative, funded by CMS and states, is expected to support more than 4,000 nurses and nursing students nationwide, offering up to $40,000 in student loan repayment or a $10,000 stipend for a three-year commitment in rural or higher labor-shortage areas. CMS has committed $100 million, with states committing at least an additional $175 million. Source: Source record, October 23, 2026.
• Lilly breaks ground on $5 billion Richmond facility to produce API and finished medicines. Eli Lilly and Company announced on Oct. 22, 2026 that it broke ground on a $5 billion manufacturing facility just west of Richmond, Virginia, the company's first fully integrated site to produce both active pharmaceutical ingredients and finished antibody-drug conjugates. The new plant is expected to create 650 high-wage jobs and about 1,800 construction jobs during construction. Source: Source record, October 22, 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.