Onder 2.6 Gerechtshof Den Haag 8 mei 2018

[0037] The human MX-1 breast carcinoma xenograft was responsive to treatment with pemetrexed disodium (ALIMTA®) with doses of 100 mg/kg and 150 mg/kg producing tumor growth delays of 17 days and 21 days, respectively. Folic acid was administered to the animals alone at two doses 6 mg/kg and 60 mg/kg on the same schedule as pemetrexed disodium (ALIMTA®) and produced tumor growth delays of 7 days and 12 days, respectively. Vitamin B12 administered alone at a dose of 165 mg/kg resulted in a tumor growth delay of 12 days. Combinations of pemetrexed disodium (ALIMTA®) at each of the two doses were administered along with each of the vitamins as simultaneous combination regimens. Administration of folic acid (6 mg/kg) along with pemetrexed disodium (ALlMTA®) did not alter the tumor growth delay produced from that obtained with pemetrexed disodium (ALlMTA®) alone. The addition of folic acid at the higher dose (60 mg/kg) along with each dose of pemetrexed disodium (ALIMTA®) resulted in small increases in tumor growth delay to 22 days and 23 days at the pemetrexed disodium (ALlMTA®) doses of 100 mg/kg and 150 mg/kg, respectively. The tumor growth delays with pemetrexed disodium (ALIMTA®) and vitamin B12 (165 mg/kg) treatment were 22 days and 24 days at pemetrexed disodium (ALIMTA®) doses of 100 mg/kg and 150 mg/kg, respectively. Body weight was used as a general measure of toxicity for each of the treatment regimens. The body weight loss pattern reflected the treatment regimens with weight decrease during the treatment times of days 7 through 11 and 14 through 18 with some weight recovery during the intervening two days. The weight loss due to pemetrexed disodium (ALIMTA®) was dose dependent but overall minor (3%). Folic acid alone at either 6 mg/kg or 60 mg/kg did not cause weight loss, in fact folic acid treated animals maintained weight and gained weight over the course of the experiment better than the control animals. The animals treated with pemetrexed disodium (ALIMTA) (100 mg/kg) and folic acid (60 mg/kg) gained weight (about 20%) over the course of the experiment.

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