美国制药巨头辉瑞公司最近宣布，其开发的palbociclib最近获得了FDA相关部门的肯定，这也为palbociclib的最终上市扫清了障碍。Palbociclib是通过阻断CDK4和CDK6两种酶来治疗患有转移性乳腺癌的绝经期妇女患者。FDA的相关官员对辉瑞公司此次提交的临床二期数据表示满意。而FDA作出这一决定的时间比其最终期限提前了两个月之多，这也为辉瑞公司在竞争激烈的CDK抑制剂药物开发市场中取得领先位置提供了便利。目前辉瑞公司在这一领域中的主要对手包括了礼来和诺华等制药巨头。
分析人士预计，一旦palbociclib获得FDA的最终批准上市，其年销售额峰值将达到30亿-50亿美元之多。通常，许多抗癌药物都是通过作用于表皮生长因子受体来达到抗肿瘤效果，而目前发现很多乳腺癌患者并不表达这种受体。Palbociclib的创新之处就在于这种药物的靶向目标变为了雌激素受体。从而为这类乳腺癌患者提供了新的选择。同时，FDA还表示palbociclib还有望与另一种抗癌药物letrozole联合治疗专一性乳腺癌。这也是辉瑞公司在开辟自己的肿瘤疗法研发部门后取得的首个胜利。
新年伊始，辉瑞公司正在大刀阔斧地开辟自己的肿瘤药物部门。去年，辉瑞公司曾经尝试以1180亿美元的的价格收购阿斯利康，以获得其继续的肿瘤免疫疗法研发部门，然而由于各方面的原因，这一收购案最终胎死腹中。不过，辉瑞公司并未就此偃旗息鼓。不久，辉瑞公司就和德国默克公司签订了价值数亿美元的肿瘤免疫疗法研发协议。或许2015年将成为辉瑞公司研发部门重组后的一个丰收年。
Pfizer ($PFE) picked up a speedy FDA nod for palbociclib, a breast cancer treatment with blockbuster potential, barreling toward the market as it works to carve out a bigger share of the oncology space.
The drug, which works by inhibiting the enzymes CDK4 and CDK6, is now cleared for use in postmenopausal women with metastatic breast cancer. The approval is based on Phase II data and comes more than two months ahead of the agency's decision deadline, completing what has been a charmed trip through the regulatory process for Pfizer. The oral treatment, which will sell as Ibrance, is expected to bring in sales between $3 billion and $5 billion a year at its peak, according to Leerink analyst Seamus Fernandez.
The approval puts Pfizer ahead of a coming crowd of CDK inhibitors, including promising contenders from Eli Lilly ($LLY) and Novartis ($NVS), and gives the company a first major success as it begins a new era in cancer treatments. Palbociclib's lightning-fast approval also affirms FDA oncology chief Richard Pazdur's willingness to hurry along so-called breakthrough treatments that could change the standard of care, a cause for optimism among developers of similar drugs.
Pfizer's drug is specifically indicated for women whose cancers respond to estrogen receptor but don't express human epidermal growth factor receptor 2 (HER2), and it's to be used in combination with the oncology drug Femara (letrozole), the FDA said.
"The addition of palbociclib to letrozole provides a novel treatment option to women diagnosed with metastatic breast cancer," Pazdur said in a statement. "The FDA is committed to expediting marketing approval of cancer drugs through our accelerated approval regulations."
Pfizer is moving on from last year's pursuit of AstraZeneca ($AZN), a $118 billion gambit driven largely by the allure of that 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 the titans of the field, payingMerck KGaA $850 million up front for the PD-L1 inhibitor MSB0010718C and promising as much as $2 billion more to collaborate on up to 20 new cancer immunotherapies.
The deal took the pressure the pressure off of Pfizer and its business development squad in the aftermath of the AstraZeneca debacle, CEO Ian Read said last month, adding that "our research pipeline, middle stage to late stage, is strong, and I would rather take our capital right now and direct it to opportunities to accelerate EPS growth."
And palbociclib's success is an affirmation of Pfizer's ability to compete with the leaders in oncology, Read said in a statement Tuesday.
"I am proud of the clinical program for Ibrance, which was discovered in Pfizer laboratories, and the innovation we are able to bring forward to the breast cancer community today," Read said."... Today's FDA approval of Ibrance marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need and underscores the contributions our company can make to society."
Pfizer's late-stage pipeline includes bococizumab, a member of a newfangled class of cardio therapies with blockbuster expectations, and ertugliflozin, a Merck ($MRK)-partnered diabetes treatment.
