CHMP recommends RYBREVANT + chemo for the treatment of adult patients with advanced EGFR-mutated NSCLC after failure of prior therapy

“EGFR gene mutations are the most common actionable oncogenic mutations in NSCLC, with ex19del or L858R mutations representing up to 90 percent of all EGFR mutations,” said Henar Hevia, Ph.D., Senior Director, EMEA Therapeutic Area Lead, Oncology, Johnson & Johnson Innovative Medicine. “At Johnson & Johnson, our dedication to transforming the treatment of lung cancer with innovative therapies is unwavering, and we are proud to take another step forward for patients in need of new, targeted treatment options.”

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“Between 2017 and 2023, the socioeconomic burden of HER2-positive breast cancer in ten major economies was nearly $590 billion, projected to increase to nearly $1,000 billion by 2032,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “At-home treatment may help alleviate the pressure

Richard Saynor, CEO of Sandoz, said: “The global burden of cancer continues to grow and the potential to address unmet patient needs has never been greater. This agreement offers us the chance to reach many more millions of patients, while helping to drive the long-term sustainability of healthcare systems.”

“Beyond the second-line monotherapy opportunity, we and our partners at Pfizer have removed plans for a Phase 3 first-line combination trial with atirmociclib, as well as the planned Phase 3 second-line combination trial with a CDK4/6 inhibitor, from our joint development plan,” continued Dr. Houston. “This decision was made following

“The interim PFS analysis results demonstrated that, compared to the current standard treatment, KN026 in combination with chemotherapy significantly improved PFS, reduced the risk of disease progression or death, and showed a trend toward OS benefit. Detailed data from this study will be presented at an upcoming international academic conference.”