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Pfizer Reveals Data from P-III (BREAKWATER) trial of Braftovi Regimen in Patients with Metastatic Colorectal Cancer

Shots:Pfizer reported topline data of P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in untreated BRAF V600E-mutant mCRC pts, randomized to Braftovi + Erbitux (n=158), Braftovi + Erbitux + mFOLFOX6 (n=236), or CT (mFOLFOX6/ FOLFOXIRI/ CAPOX) ± Avastin (n=243) Study showed improved PFS (1EP) & OS (2EP) along with previously reported improved cORR…

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Insights+ Key Biosimilars Events of June 2024

Insights+ Key Biosimilars Events of June 2024

Shots:   Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency    Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients    The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…

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The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC) 

Shots: The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3%…

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Takeda

Takeda’s Fruquintinib Gains the CHMP’s Positive Opinion for Previously Treated Metastatic Colorectal Cancer 

Shots: The CHMP has granted positive opinion to the company’s fruquintinib (VEGFR-1, -2 & -3 inhibitor) for previously treated metastatic colorectal cancer (mCRC) adults. Takeda holds its exclusive global rights outside of mainland China, Hong Kong & Macau while HUTCHMED has China rights The opinion was based on P-III (FRESCO-2) study assessing fruquintinib + best…

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VIEWPOINTS_Volker Wacheck_2024

Volker Wacheck Discusses the Approval of the Lonsurf Combination Drug for the Treatment of Colorectal Cancer

Shots: Volker Wacheck sheds light on the recent approval of Lonsurf in combination with bevacizumab for patients with metastatic colorectal cancer While sharing key insights from the pivotal P-III (SUNLIGHT) trial evaluating Lonsurf ± bevacizumab, Volker reveals that the combination drug is proven to prolong both OS and PFS along with QoL benefits and a…

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Viewpoints_Mark Erlander

PharmaShots Interview: Cardiff Oncology’s Mark Erlander Shares Insight on the P-I Data of Onvansertib for Metastatic Colorectal Cancer

In an interview with PharmaShots, Mark Erlander, CEO of Cardiff Oncology shared his views on the data presented at the ASCO-GI Conference, P-Ib results of Onvansertib, what these results meant for the patients with this aggressive type of mCRC, and the company's other ongoing programs for Onvansertib, including metastatic castration-resistant prostate cancer and AMLShots:The data presented at ASCO-GI showed…

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