{"id":86919,"date":"2026-06-18T14:58:44","date_gmt":"2026-06-18T14:58:44","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/86919\/"},"modified":"2026-06-18T14:58:44","modified_gmt":"2026-06-18T14:58:44","slug":"jazz-roches-small-cell-lung-cancer-combo-snags-fda-approval","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/86919\/","title":{"rendered":"Jazz, Roche’s small cell lung cancer combo snags FDA approval"},"content":{"rendered":"

An FDA approval is setting a new benchmark for future treatment for first-line small cell lung cancer.<\/p>\n

The FDA has greenlighted<\/a> Jazz Pharmaceuticals\u2019 Zepzelca, used in combination with Roche\u2019s Tecentriq, as a first-line maintenance treatment in extensive-stage small cell lung cancer (ES-SCLC), the agency said Thursday. The approval also applies to Tecentriq Hybreza, a subcutaneous version of the Roche PD-L1 inhibitor.<\/p>\n

First-line maintenance treatment is for patients who have not progressed after initial induction therapy. Before Thursday\u2019s approval, Tecentriq in combination with chemotherapy, followed by Tecentriq alone, has been a standard of care in first-line ES-SCLC. The newly FDA-approved regimen now adds Jazz\u2019s Zepzelca, which is also a chemotherapy drug, during the maintenance phase.<\/p>\n

\u201cFor people with extensive-stage small cell lung cancer and their families, the period after induction therapy is often filled with uncertainty, given the high risk of relapse,\u201d Roy Herbst, M.D., Ph.D., from the Yale School of Medicine said<\/a> in an Oct. 3 statement. The FDA approval of Tecentriq and Zepzelca \u201cmay lead to a meaningful shift in how we manage this challenging disease and gives us a new tool to help to delay disease progression and extend survival,\u201d he added.<\/p>\n

Herbst was a member of the steering committee for the phase 3 IMforte trial that convinced the FDA of Zepzelca and Tecentriq\u2019s treatment effect. Adding Zepzelca reduced the risk<\/a> of death by 27% more than Tecentriq alone during the maintenance phase. Those who got the combo lived a median 13.2 months, versus 10.6 months among patients in the Tecentriq arm.<\/p>\n

Patients on the combo also had a 46% lower risk of cancer progression or death. \u00a0The median progression-free survival time was 5.4 months for the combo versus 2.1 months for Tecentriq alone.<\/p>\n

When the data were shared at the American Society of Clinical Oncology (ASCO) annual meeting this year, ASCO Chief Medical Officer Julie Gralow, M.D., noted that there\u2019s still room for improvement in first-line ES-SCLC as the regimen\u2019s progression-free survival is still quite short.<\/p>\n

Nevertheless, the FDA approval, along with a recent addition as a preferred regimen on the National Comprehensive Cancer Network (NCCN) guidelines, is making Tecentriq-plus-chemo, followed by Tecentriq and Zepzelca, as the new efficacy benchmark in first-line ES-SCLC. The NCCN recommendation for the new combo is currently rated at category 2A, which is lower than the original Tecentriq regimen\u2019s category 1.<\/p>\n

While near-term applications with the FDA do not have to produce a direct head-to-head comparison with the regimen, industry watchers and research doctors will certainly compare any new data in first-line ES-SCLC with the IMforte regimen.<\/p>\n

This will affect views on Amgen\u2019s DeLLphi-305 trial for adding the DLL3 T-cell engager Imdelltra to AstraZeneca\u2019s Imfinzi also in the first-line maintenance setting. The trial, which kicked off in June 2024, has Imfinzi maintenance alone as the comparator arm.<\/p>\n

It will also affect future interpretation of results from BioNTech and its partner Bristol Myers Squibb\u2019s relatively new phase 3 Rosetta Lung-01 trial for their PD-L1xVEGF bispecific pumitamig<\/a> (BNT327) in first-line ES-SCLC.<\/p>\n","protected":false},"excerpt":{"rendered":"An FDA approval is setting a new benchmark for future treatment for first-line small cell lung cancer. The…\n","protected":false},"author":2,"featured_media":86920,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[9980,44312,2991,41488,41939,16015,146,265,2536,134,9975,7780],"class_list":["post-86919","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-combination-therapy","tag-drug-combinations","tag-fda-approval","tag-fda-approvals","tag-fierce-pharma-homepage","tag-jazz-pharmaceuticals","tag-marketing","tag-oncology","tag-pharma","tag-roche","tag-small-cell-lung-cancer","tag-tecentriq"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116771704402922708","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/86919","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=86919"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/86919\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/86920"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=86919"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=86919"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=86919"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}