Zolbetuximab

Roche's VENTANA CLDN18 (43-14A) RxDx Assay is the first FDA-approved IHC companion diagnostic for identifying CLDN18 protein expression in gastric/GEJ adenocarcinoma, aiding in treatment eligibility for Astellas' VYLOY (zolbetuximab).

Astellas announces FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer, based on SPOTLIGHT and GLOW trials. VYLOY is the first CLDN18.2-targeted therapy in the U.S.

Oncology dominates pharmaceutical innovation, with 1,600 cancer drugs in development. Spending on cancer drugs is projected to reach $409 billion by 2028, with high costs for novel agents. Biosimilars and generics may provide savings but cannot match rising expenditures. The focus is shifting towards cell therapies for solid tumors, with 44% of trials initiated in 2023 targeting solid tumor indications. Several cancer drugs have been approved by the FDA this year, and many more are expected to receive approval decisions soon.

Q3 2024 saw approval of 5 novel antibody drugs, increased ADC research, and $3B in collaborations. Investment in antibodies continues, with startups raising up to $370M. Promising antibodies for Q4 include treatments for genetic disorders and cancers.

Zolbetuximab, a drug targeting claudin 18.2 in gastric cancer, has been approved in Europe after trials showing it prolongs survival and delays disease progression. Developed in Germany, it is administered with chemotherapy and will be available in Germany by year-end.

Zolbetuximab, a drug targeting claudin 18.2 in gastric cancer, has been approved in Europe after clinical trials showed it prolongs survival and delays disease progression. Developed in Germany, it is administered via intravenous infusion with chemotherapy.

Roche Diagnostics' VENTANA CLDN18 (43-14A) RxDx assay received CE certification as the first immunohistochemistry test to identify CLDN18.2 expression in gastric or gastroesophageal junction adenocarcinoma patients, potentially eligible for zolbetuximab treatment. Data from SPOTLIGHT and GLOW trials supported the assay's use, showing improved outcomes with zolbetuximab plus chemotherapy. The European Commission approved zolbetuximab for advanced CLDN18.2-positive gastric cancer in 2024, and the FDA accepted a resubmission for BLA approval in May 2024.

Merck & Co’s Keytruda and Astellas/Pfizer’s Padcev approved by MHRA as first-line treatment for advanced bladder cancer, based on KEYNOTE-A39/EV-302 trial results showing 53% reduction in risk of death and extended progression-free survival.

Johnson & Johnson proposed changes to the 340B drug discount program, but backed down after HRSA deemed them inconsistent with the statute. The 340B program, established in 1992, aims to help underserved communities by allowing eligible hospitals and clinics to purchase outpatient prescription medications at discounts. Recent regulatory developments include FDA approvals for Exact Sciences' Cologuard Plus, Partners Fresenius Kabi and Formycon's Otulfi, Eli Lilly's Retevmo, Sanofi and Regeneron's Dupixent, Bristol Myers Squibb's Cobenfy, and others. Additionally, Pfizer withdrew Oxbryta from the market due to safety concerns.