日々のつれづれ

不惑をむかえ戸惑いを隠せない男性の独り言

公知申請で患者の方々に光

At the end of November, two famous drugs were approved in Japan. These drugs were often treated to breast cancer patients, but they were not approved. Therefore, many patients had to pay a lot of money to take their medications.
This news shows that nothing special in the Japanese clinic is approved at last.

This is "Drug-lag".

I heard that drug developments are recently internationalized and clinical trial are designed to proceed in many countries at the same time. If it do well, many patients lived in the different countries could take a same medication without a gap.
However, there are a lot of confinements by the law in Japan, so it is too difficult for the Japanese doctors to participate in this trials. Before I have read.

I strongly think that the most important thing is the benefit of patients.
I hope to change the medical system as soon as possible.

抗HER2抗体トラスツズマブについて、HER2過剰発現が確認された乳癌における術前補助化学療法の適応追加と、HER2過剰発現が確認された転移性乳癌における3週間1回投与の新規用法・用量が承認されたと発表した。今回の適応拡大で、トラスツズマブの乳癌に対する適応はHER2過剰発現が確認された乳癌となった。

トラスツズマブの乳癌術前投与が可能に:日経メディカル

カルボプラチンは、これまで頭頸部癌、肺小細胞癌、睾丸腫瘍、卵巣癌、子宮頸癌、悪性リンパ腫、非小細胞肺癌などに用いられていたが、今回、乳癌が追加となった。
カルボプラチンは、医療上の必要性の高い未承認薬・適応外薬検討会議での検討結果を受け、乳癌に対して公知申請に該当すると評価された。

公知申請していたカルボプラチンの乳癌に対する適応が承認:日経メディカル