CHMP recommends EU approval of Itovebi for PIK3CA-mutated, ER+ve, HER2-neg, advanced breast cancer
“The positive CHMP recommendation for the Itovebi-based regimen represents a significant step towards providing people in the EU with PIK3CA-mutated, ER-positive advanced breast cancer with a targeted therapy in the first-line setting,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This recommendation is further enforced by the recent final overall survival results from the INAVO120 study, showing the regimen can meaningfully extend survival.”
Share:
More News
“FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies,” said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. “By combining cell-selective delivery with targeted protein degradation in a single molecule,
“We are excited to expand our clinical collaboration with Roche to evaluate a second KRAS combination with potential best-in-class MTA-cooperative PRMT5 inhibitor IDE892 for pancreatic cancer patients, where there remains a high unmet medical need. IDEAYA is advancing multiple rational combination strategies for the IDE892 program, including with MAT2A inhibitor
“These encouraging initial safety observations represent an important first step in the clinical evaluation of ZI-MA4-1 and our TCR-NK platform” said Namir Hassan, Chief Executive Officer of Zelluna. “The first patient received all three planned doses, and the independent committee’s recommendation enables us to continue recruitment at the first dose
“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us