Taiho Pharmaceutical Co., Ltd. and Taiho Oncology, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved LONSURF® (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an antiEGFR therapy.

Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of:...Metastatic colorectal cancer, in combination with intravenous fluorouracil based chemotherapy for first- or second-line treatment

Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.

Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of:..Metastatic colorectal cancer, in combination with fluoropyrimidine irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen.

In patients previously treated with irinotecan–fluoropyrimidine-based ChT alone, a combination of FOLFOX–bevacizumab is recommended...

…the panel added trifluridine-tipiracil, with or without bevacizumab, as a treatment option for patients who have progressed through standard therapies.

Colorectal cancer…for patients with impaired tolerance to aggressive initial therapy, the guidelines recommend infusional 5-FU/LV or capecitabine with or without bevacizumab as an option....the panel recommends chemotherapy corresponding to initial therapy for metastatic disease (eg, FOLFIRI, FOLFOX, or CAPEOX chemotherapy alone or with bevacizumab; FOLFIRI or FOLFOX with panitumumab or cetuximab; FOLFOXIRI alone or with bevacizumab).

Taiho Oncology, Inc. and Taiho Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental new drug application (sNDA) for trifluridine/tipiracil (LONSURF®) as monotherapy or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

PFS, OS and ORR did not differ according to age (PFS P = 0.81, OS P = 0.44, ORR P = 0.50) and no interaction between age and the benefit from the intensification of upfront chemotherapy was observed (PFS Pinteraction = 0.72, OS Pinteraction = 0.54, ORR Pinteraction = 0.65). Upfront FOLFOXIRI/bev shows a favourable efficacy/safety balance in EO-mCRC.

VISNÚ-1 was a multicentre, open-label, randomised, phase III study in patients with previously untreated, unresectable, metastatic colorectal carcinoma...The intention-to-treat population comprised 349 patients (FOLFOXIRI-bevacizumab, n=172; FOLFOX-bevacizumab, n=177). Median PFS was 12.4 months (95% CI 11.2 to 14.0) with FOLFOXIRI bevacizumab...