Shots:The US FDA has granted FTD to alnodesertib + low-dose irinotecan as the 3L treatment of adults with ATM-negative metastatic colorectal cancer (mCRC)Designation was based on the P-I/II (STELLA) trial (ongoing in the US) assessing the regimen in solid tumors with ATM deficiency, which showed responses in 3L mCRC & 7 additional solid…
Shots:The US FDA has approved IND application of ABT-301 to initiate P-I/II trial for pts with metastatic colorectal cancer (mCRC)Trial will assess ABT-301 + Tevimbra (provided by Beone) + Avastin in ~66 pts across Taiwan & Australia, with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRCAdditionally, Anbogen is pursuing global licensing,…
Shots:Endevica Bio conducting P-II study in collaboration with WuXi Clinical reported the dose administration of B07 in first patient to prevent weight loss in cancer patients diagnosed with stage 4 metastatic colorectal cancer undergoing CTIn 2024, Endevica Bio completed its P-I study, with early results showing strong safety and efficacy. In current P-II…
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…
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…
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%…
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…
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…
Shots:The US FDA approved 10 NDAs and 3 BLA in August 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 89 novel products in 2023In August 2023, the major highlights drugs were Zurzuvae (zuranolone) approval for women with postpartum depression and Veopoz (pozelimab-bbfg) for children…
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…

