On January 13, 2015, Huanyu Dakang Medical News pharmaceutical giant Squibb Company ushered in a good start in 2015. The anti-cancer immunotherapy drug nivolumab developed by the company was approved last month under the trade name of Opdivo. In the first month of 2015, Opdivo heard good news again. In a comparative clinical study of kanser paru-paru conducted by Squibb, Opdivo obtained new positive research data. In this clinical study involving 272 lung cancer patients, the researchers compared the efficacy of Opdivo with the current clinical standard therapy docetaxel, and the results proved the obvious advantage of this drug in the overall survival rate of patients. Reached the primary end point expected by previous researchers.
Opdivo is currently the most popular PD-1 drug. PD-1 is a cell cycle checkpoint protein. Its runaway causes tumor cells to escape immune monitoring in the body. According to the decision made by the FDA last month, Opdivo was approved for the treatment of melanoma (related reading: FDA approved Squibb PD-1 inhibitor Nivolumab (Opdivo) three months in advance, the same price as Keytruda) Similar drugs in this field are Keytruda from Merck. The results of Squibb ’s clinical research have made Opdivo the first PD-1 drug to treat lung cancer. More importantly, this result will help Squibb to lead its competitors in PD-1 drug research. Pharmaceutical companies currently active in this area include biomedical giants such as Merck, Roche and AstraZeneca.
Squibb mendedahkan bahawa syarikat itu telah menyerahkan permohonan Opdivo untuk rawatan tanda-tanda kanser paru-paru kepada FDA dan pentadbiran farmaseutikal EU. Sudah tentu, Syarikat Squibb yang bercita-cita tinggi bukan sahaja akan berpuas hati dengan kanser paru-paru dan melanoma. Malah, Squibb kini sedang menjalankan lebih daripada 35 kajian Opdivo sahaja atau digabungkan dengan ubat lain untuk merawat jenis tumor yang berbeza. Menurut penganalisis, jualan masa depan Opdivo akan mencecah setinggi 5 bilion dolar AS.
Kanser itu imunoterapi research that has emerged in recent years has brought new hope for humans to conquer the disease of cancer. Almost all biomedical giants are planning in this field, hoping to share a cake. However, it is not yet known who will be the biggest winner in this technological revolution.
Laporan Bahasa Inggeris terperinci:
Ubat immuno-o ncology terkemuka Bristol-Myers Squibb ($ BMY) nivolumab, yang diluluskan pada bulan lalu sebagai Opdivo, mencatatkan kejayaan yang memberangsangkan dalam percubaan kanser paru-paru peringkat akhir, menguatkan jangkaan jualan untuk rawatan perintis.
Dalam kajian 272 pesakit yang mengadu Opdivo dengan docetaxel pembunuh kanser standard, demonstrasi ubat Bristol-Myers menunjukkan kemandirian keseluruhan yang unggul berbanding dengan bahagian pengawal yang mencapai titik akhir utamanya lebih awal daripada jadual, mengetuai cadangan jawatankuasa pemantau data percubaan. pengajian ditamatkan awal. Bristol-Myers kini menjemput pesakit dalam kumpulan docetaxel untuk memilih Opdivo melalui kajian sambungan label terbuka.
Rawatan Bristol-Myers direka untuk merangsang serangan sistem imun terhadap tumor dengan menyekat laluan yang dipanggil PD-1, yang, jika dibiarkan, membolehkan sel-sel kanser berlalu tanpa dikesan oleh pertahanan semula jadi badan. Seperti Keytruda serupa Merck ($ MRK), Opdivo memenangi kelulusan FDA tahun lepas sebagai rawatan untuk melanoma, tetapi ubat Bristol-Myers berdiri sendiri dalam kanser paru-paru, kerana kejayaan klinikal terbarunya menandakan kali pertama perencat PD-1 mencatatkan kelebihan kelangsungan hidup terhadap penyakit itu, kata syarikat itu.
Opdivo’s particular promise in barah paru-paru sel yang tidak kecil has led analysts to pencil it in as the most commercially promising among therapies that block PD-1 and the related PD-L1, putting Bristol-Myers ahead of Merck, Roche ($ RHHBY), AstraZeneca ($ AZN) and others. Analysts figure Opdivo will bring in peak sales of around $ 5 billion, and Leerink’s Seamus Fernandez believes the treatment’s potential in lung cancer will take it as high as $ 7.3 billion by 2020. The entire class of therapies is expected to bring in a bout $ 35 billion a year.
Bristol-Myers telah mengemukakan permohonan kanser paru-paru di AS dan Eropah untuk Opdivo dalam kanser paru-paru, menjangkakan untuk meluaskan penggunaan ubat itu lewat tahun ini.
Like its competitors, Bristol-Myers has mounted an expansive R & D program for its PD-1 candidate, running more than 35 trials in total that test Opdivo alone or as part of a cocktail in renal cell carcinoma, kanser kepala dan leher, glioblastoma, Non-Hodgkin lymphoma and other cancers.
