2014年FDA和EMA批准用于治疗实体瘤的新药

下面所列的肿瘤治疗药物是在2014年被美国FDA和/或欧洲药品管理局（EMA）审批通过的。批准的适应症列在药物名称的下面。

Cyramza (ramucirumab)

Ramucirumab被FDA批准用于单独或联合紫杉醇治疗晚期胃癌或胃食管交界处腺癌，用于那些对含氟尿嘧啶或含铂类化疗方案治疗后发生进展的患者。Ramucirumab也别批准与多西紫杉醇联用治疗转移性非小细胞肺癌，用于铂类化疗方案治疗后发生进展的患者。表皮生长因子受体（EGFR）或间变性淋巴瘤激酶（ALK）基因突变的肿瘤患者，在接受ramucirumab治疗之前，应接受FDA批准的相应治疗。

Ramucirumab被EMEA批准用于联合紫杉醇治疗晚期胃癌或胃食管交界处腺癌，用于那些对含氟尿嘧啶或含铂类化疗方案治疗后发生进展的患者。Ramucirumab单药治疗晚期胃癌或胃食管交界处腺癌，用于那些对含氟尿嘧啶或含铂类化疗方案治疗后发生进展的不适用于联合紫杉醇治疗的患者。

Zykadia (Ceritinib)

Ceritinib被FDA批准用于治疗间变性淋巴瘤激酶（ALK）阳性的转移性非小细胞肺癌，用于克唑替尼治疗后发生进展或者对crizotinib不耐受的患者。由于肿瘤反应速度和反应时间，这个适应症得到了加速审批。

Keytruda (Pembrolizumab)

FDA批准Pembrolizumab用于治疗不可切除的或转移性黑色素瘤，用于伊匹单抗ipilimumab治疗后发生进展的患者，如果BARF V600突变阳性，该药可作为BARF的抑制剂。

Mekinist (trametinib)

FDA批准Trametinib用于单药治疗或联合dabrafenib治疗不可切除的或转移性黑色素瘤，这些患者经FDA批准的检测方法发现BRAF V600E或V600K突变阳性。Trametinib去年被批准用于单药治疗BRAF V600E或 V600K突变阳性的不可切除的或转移性黑色素瘤。

EMEA在2014年批准Trametinib治疗不可切除的或转移性黑色素瘤，用于BRAF V600突变的成年患者。

Cometriq (cabozantinib)

FDA于2012年批准Cabozantinib用于治疗进展的转移性甲状腺髓样癌。EMEA在2014年批准Cabozantinib用于成年患者，治疗进展的、不可切除的局部晚期或转移性甲状腺髓样癌。

Akynzeo (netupitant/palonosetron)

Netupitant/palonosetron被FDA批准用于预防肿瘤化疗开始时和重复化疗时导致的急性和延迟性恶心呕吐，包括高度导致呕吐的化疗方案，但并仅限于此类方案。口服palonosetron预防急性恶心呕吐，奈妥吡坦预防化疗后的急性和延迟性恶心呕吐。

Lynparza (olaparib)

FDA批准Olaparib单独给药治疗晚期卵巢癌，用于三种或更多化疗方案治疗后毒性较强或可疑毒性较强导致生殖细胞BRCA突变（获FDA批准的测试）的患者。

ENEA批准Olaparib单独给药用于成年患者的维持治疗，治疗铂类药物敏感的复发的BRCA基因突变（生殖细胞系和/或体细胞系）的高级别浆液性卵巢上皮、输卵管或原发性腹膜肿瘤，用于那些对铂类化疗方案有完全或部分反应的患者。

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The following oncology drugs were approved by the FDA in the US and/or the EMEA in Europe in 2014. The approved indications are listed with the drug and the drug name is hyperlinked to its package insert.

Ramucirumab (Cyramza)

FDA:

As a single agent or in combination with paclitaxel for treatment of advanced gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

In combination with docetaxel for treatment of metastatic non–small cell lung cancer with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving ramucirumab.

EMEA:

In combination with paclitaxel for treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior fluoropyrimidine- or platinum-containing chemotherapy.

As monotherapy for treatment of advanced gastric cancer or gastroesophageal junction adenocarcinoma with disease progression after prior fluoropyrimidine- or platinum-containing chemotherapy for patients in whom treatment in combination with paclitaxel is not appropriate.

Zykadia (Ceritinib)

FDA:

For treatment of anaplastic lymphoma kinase (ALK)–positive metastatic non–small cell lung cancer for patients who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response.

Keytruda (Pembrolizumab)

FDA:

For treatment of unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation–positive, a BRAF inhibitor.

Trametinib (Mekinist)

FDA:

Indicated as a single agent and in combination with dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.

Approved last year for single-agent treatment of BRAF V600E– or V600K mutation–positive unresectable or metastatic melanoma.

EMEA:

Treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Cabozantinib (Cometriq)

FDA:

Approved in 2012 for progressive metastatic medullary thyroid cancer.

EMEA:

Indicated for adult patients with progressive, unresectable locally advanced or metastatic medullary thyroid carcinoma.

Netupitant/palonosetron (Akynzeo)

FDA:

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

Oral palonosetron prevents acute nausea and vomiting, and netupitant prevents both acute and delayed nausea and vomiting after cancer chemotherapy.

Olaparib (Lynparza)

FDA:

Monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-approved test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

EMEA:

Indicated as monotherapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.