据辉瑞公司方面消息，公司即将向FDA提交关于其开发的乳腺癌药物palbociclib。这也标志着辉瑞在收购阿斯利康公司失败之后，开始尝试建立自己的肿瘤研发部门。公司预期这一药物将在今年4月13日之前获得FDA的最终批准，同时FDA也已经表示不需要辉瑞等候FDA下属的专家委员会建议通过。这一决定暗示palbociclib最终获得通过的可能性相当之高。
时间回到2014年八月份，辉瑞公司在向FDA提交关于palbociclib的临床二期研究数据后，获得了FDA的高度评价。所有这些消息都促成了辉瑞公司对palbociclib上市前景的巨大信心。分析人士预计，palbociclib一旦获得批准，其每年销售额最高可达到30亿-50亿美元之多。
事实上，辉瑞公司此前花费超过1千亿美元的价格收购阿斯利康的重要原因之一就是希望借此组建自己的肿瘤免疫疗法研发部门。不过，现在来看，没有阿斯利康的帮助，辉瑞公司仍然朝着预定目标在不断前进。公司先后与默克等公司建立了合作研发协议，以试图在这一领域遥遥领先的诺华、默沙东等医药巨头。可以想见，2015年的肿瘤免疫疗法市场上，又将出现一场场龙争虎斗。
详细英文报道：
Pfizer ($PFE) appears to be speeding toward a crucial early FDA approval for palbociclib, a breast cancer treatment with blockbuster potential, pivoting from its failed bid for AstraZeneca ($AZN) and building up an oncology pipeline of its own.
The company is expecting to get final word on the drug by April 13,revealing today that the FDA isn't going to require it to go through a panel of agency advisers in the meantime. That makes approval look all the more likely to a few analysts, good news for a treatment that has thus far had a charmed trip through the regulatory process. Pfizer submitted a palbociclib application with only Phase II data back in August, quickly winning the FDA's priority review designation and lining it up for an early approval.
Skipping the advisory panel process, in which independent experts vote whether to recommend approval, could be a sign the agency has already made up its mind, Evercore ISI analyst Mark Schoenebaum wrote in a note to investors. And while the agency could well reject palbociclib anyhow, Schoenebaum believes the news a net positive for Pfizer. Leerink's Seamus Fernandez, who sees this development as a likely prelude to a regulatory OK, figures the drug could be worth between $3 billion and $5 billion a year at its peak.
Approval for palbociclib, which Pfizer plans to market as Ibrance, would help set the stage for what the company hopes will be a bright future in cancer treatments. Pfizer has apparently moved on from last year's pursuit of AstraZeneca, a $118 billion gambit driven largely by the allure of the latter company's immuno-oncology pipeline. In the ensuing months, Pfizer struck a slew of deals to cobble together some promising new assets that could help it catch up with immuno-oncology titans Bristol-Myers Squibb ($BMY), Merck ($MRK) and Roche ($RHHBY) without the need for a big buyout.
Headlining Pfizer's swing into immuno-oncology is a deal with Germany's Merck KGaA, signed in November, under which the U.S. drugmaker will pay $850 million up front and as much as $2 billion more in order to collaborate on up to 20 new cancer immunotherapies. Pfizer also struck a smaller deal with biotech iTeos Therapeutics, handing over a $30 million down payment to get its hands on preclinical drugs that target IDO1 and TDO2, cancer-expressed enzymes that break down tryptophan, which is integral to the immune system's ability to recognize tumors.
The goal is to contend with industry's biggest oncology outfits, reversing its trend of checkered results in cancer R&D and building a sustained presence in the field. Palbociclib, which leads similar therapies from Novartis ($NVS) and Eli Lilly ($LLY), is the first big step forward, and Pfizer could use the victory.
