--- title: 'Life Sciences Daily Summary: What Happened on October 21, 2026' headline: GSK wins rectal cancer approval as Tezspire succeeds in Phase III description: The FDA also approved GSK’s hepatitis B drug, while UK regulators changed course on medical devices and a chikungunya vaccine. url: https://thebench.bio/news/summaries/2026-10-21 topic: all date: '2026-10-21' covers: - '2026-10-21' date_published: '2026-10-21T12:06:21Z' date_modified: '2026-10-21T12:06:21Z' tags: - Regulatory - Clinical - Industry sources: 8 publisher: TheBench.Bio --- # Life Sciences Daily Summary: What Happened on October 21, 2026 **GSK wins rectal cancer approval as Tezspire succeeds in Phase III** The FDA also approved GSK’s hepatitis B drug, while UK regulators changed course on medical devices and a chikungunya vaccine. ## Today in brief The FDA cleared GSK’s Jemperli for some locally advanced rectal cancers, and Amgen and AstraZeneca said Tezspire met both primary endpoints in a Phase III trial for eosinophilic esophagitis. [1] [2] Great Britain will keep recognizing CE-marked medical devices long term, while its regulator withdrew approval for Valneva’s chikungunya vaccine Ixchiq. [3] [4] The FDA approved GSK’s Hibsago on October 20 for certain adults with chronic hepatitis B, to be used with existing antiviral treatment. [5] [6] ## Jemperli gains FDA approval for some locally advanced rectal cancers The FDA granted accelerated approval to GSK’s Jemperli for adults with stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). [1] [7] [8] Patients must have the relevant tumor marker confirmed with an FDA-authorized test. [8] The decision drew on interim results from AZUR-1, a single-arm Phase II study of 154 patients. [7] Investigator-assessed data showed a 68% response rate at 12 months, while independent-review results were still maturing at 47%. [7] At a median follow-up of more than two years, nearly three-quarters of participants had avoided surgery, radiation, or chemotherapy. [8] Because the approval is accelerated, GSK must provide further clinical data to confirm lasting benefit. [7] [8] ## Tezspire meets both Phase III endpoints in eosinophilic esophagitis Amgen and AstraZeneca said Tezspire met both primary endpoints at week 24 in the Phase III CROSSING trial, which enrolled 368 adolescents and adults with eosinophilic esophagitis. [2] The drug is injected every four weeks and blocks thymic stromal lymphopoietin, a protein involved in epithelial inflammation. [2] At week 24, tissue remission occurred in 64.8% of patients on 210 mg and 68.9% on 420 mg, compared with 3.5% on placebo. [2] Swallowing-symptom scores fell by 18.8 and 22.0 points with the two doses, versus 14.7 points with placebo. [2] The companies said improvements continued through week 52, when remission rates were 67.8% and 63.3% on Tezspire, compared with 5.4% on placebo. [2] The reported safety profile matched that seen with Tezspire’s approved uses. Diarrhea, headache, and nasopharyngitis were among the most common adverse events. [2] ## Great Britain will keep recognizing CE-marked medical devices The UK government confirmed that Great Britain will continue recognizing CE-marked medical devices long term, so devices approved for the EU market will not need a separate UK approval route under this arrangement. [3] More than 90% of devices registered for use in Great Britain currently carry a CE mark. [3] The Medicines and Healthcare products Regulatory Agency will continue overseeing devices sold in the UK and monitoring safety through channels including Yellow Card. [3] The UKCA pathway remains in place, and the government is developing legislation to update its requirements and enable a future medical-device licensing approach. [3] ## MHRA withdraws approval for Valneva’s Ixchiq vaccine The UK Medicines and Healthcare products Regulatory Agency withdrew Ixchiq’s marketing approval after reviewing post-market information and consulting the Commission on Human Medicines. [4] The agency concluded that the vaccine’s benefits no longer outweighed its risks for chikungunya prevention. [4] UK health professionals can no longer prescribe, supply, or administer Ixchiq, and the regulator directed that remaining supplies be disposed of. [4] Valneva disagreed with the decision but said it would not appeal. Bavarian Nordic’s Vimkunya is the UK’s other approved chikungunya vaccine. [4] Reports among Ixchiq recipients included three deaths, and analyses indicate the vaccine can cause chikungunya-like illness and rare neurological events such as encephalitis. [4] The FDA suspended Ixchiq’s US license in August 2025, citing serious safety concerns. [4] ## FDA approves GSK’s Hibsago for certain adults with chronic hepatitis B On October 20, the FDA approved Hibsago with existing antiviral medicine for certain adults with chronic hepatitis B who do not have cirrhosis. [5] [6] It is the first FDA-approved antisense oligonucleotide for chronic hepatitis B. The agency also authorized a Roche companion diagnostic to help identify and monitor eligible patients. [5] Eligible patients must have received antiviral treatment for at least six months, have suppressed hepatitis B levels, and have a surface-antigen level of 3,000 IU/mL or less. [5] Across two trials, 24% of Hibsago recipients met criteria to stop their existing medicine, compared with none on placebo. [5] At 24 weeks after stopping all hepatitis B treatment, 19% of Hibsago recipients still had controlled virus and undetectable surface antigen. The drug carries a boxed warning for serious liver reactions and low platelet counts. [5] ## The day in numbers - **68%**: Investigator-assessed response rate at 12 months in AZUR-1, the study supporting Jemperli’s accelerated approval. [7] - **64.8% and 68.9%**: Week-24 tissue-remission rates on Tezspire’s 210 mg and 420 mg doses, respectively, versus 3.5% on placebo. [2] - **More than 90%**: Share of medical devices registered for Great Britain that carry a CE mark. [3] - **24%**: Share of Hibsago recipients who met criteria to stop their existing hepatitis B medicine, compared with none on placebo. [5] ## Sources 1. [GSK’s Jemperli gains rectal cancer approval as rivals advance across colorectal settings](), BioCentury, 2026-10-21 2. [Amgen and AstraZeneca report Phase III Tezspire data for EoE](), Clinical Trials Arena, 2026-10-21 3. [Government confirms indefinite recognition of CE marked medical devices](), MHRA, 2026-10-21 4. [MHRA revokes approval for Valneva’s Ixchiq due to safety frailties](), Pharmaceutical Technology, 2026-10-21 5. [FDA Approves First-of-Its-Kind Chronic Hepatitis B Treatment](), FDA Press Announcements, 2026-10-20 6. [GSK wins FDA green light for chronic hep B treatment Hibsago](), pharmaphorum, 2026-10-21 7. [Pharmaceutical Executive Daily: FDA Grants Accelerated Approval to Jemperli](), Pharmaceutical Executive, 2026-10-20 8. [GSK Immunotherapy Gets Accelerated FDA Approval for Treating Rectal Cancer](), MedCity News, 2026-10-20 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: