百时美施贵宝公司的Opdivo®（nivolumab）现在是FDA批准的第一个

StephenW

Bristol-Myers Squibb’s Opdivo® (nivolumab) Now the First and Only FDA-Approved PD-1 Inhibitor to Offer Every Four-Week Dosing

U.S. Food and Drug Administration approves Opdivo label update offering flexible flat-dosing options every two weeks (240 mg) or every four weeks (480 mg)1

Opdivo also now approved for shorter 30-minute infusions, cutting previous infusion time in half1
March 06, 2018 06:59 AM Eastern Standard Time

PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.1 This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.1 Opdivo also was approved for a shorter 30-minute infusion across all approved indications.1 Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future.


“At Bristol-Myers Squibb, we are united in our mission to fight cancer from all angles and recognize every patient has unique needs. From the introduction of our first Immuno-Oncology agent through today’s approval of flexible dosing options at two- or four-week intervals, we are relentless in pursuing innovative options for the cancer community,” said Johanna Mercier, head, U.S. Commercial, Bristol-Myers Squibb. “With this approval, we now offer the most robust range of dosing options for an Immuno-Oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.”

Bristol-Myers Squibb’s strong heritage in Immuno-Oncology underpins this approval, which builds on the company’s experience in developing agents that use the body’s own immune system to help fight cancers. The Q4W (480 mg) flat dose option is approved for the following indications for Opdivo:

    Metastatic melanoma (monotherapy or monotherapy phase after combination treatment with Yervoy® [ipilimumab])1,2
    Previously treated metastatic non-small cell lung cancer1
    Advanced renal cell carcinoma following prior anti-angiogenic therapy1
    Previously treated locally advanced or metastatic urothelial carcinoma following disease progression during or after platinum-based chemotherapy1
    Classical Hodgkin lymphoma following relapse/progression after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or three or more lines of systemic therapy that includes autologous HSCT1
    Recurrent/metastatic squamous cell carcinoma of the head and neck following platinum-based therapy1
    Hepatocellular carcinoma after prior sorafenib therapy1
    Adjuvant therapy for patients with completely resected melanoma with lymph node involvement or metastatic disease1

Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; complications of allogeneic HSCT after Opdivo; and embryo-fetal toxicity.1

With the expanded label, the following dosing schedule options are immediately available:
                        
Schedule                       Dosage
Q2W1                       240 mg (now available in one vial)1
Q4W1                       480 mg1
                     

“We continuously learn new ways to individualize treatment with Immuno-Oncology therapies, and in my experience, what works for one patient may not be optimal for another,”3 said Jeffrey S. Weber, M.D., Ph.D., deputy director of the Perlmutter Cancer Center at NYU Langone Health and professor of medicine at NYU School of Medicine. “For instance, some patients may need the support of two-week visits with their health care team, while for others, a four-week interval may be more appropriate and better suited to their treatment needs.4 With this approval, we now have additional ways to help tailor patient care.”

INDICATIONS

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) as a single agent is indicated for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with 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 OPDIVO.

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (10 mg/mL) is an injection for intravenous (IV) use.

StephenW

百时美施贵宝公司的Opdivo®（nivolumab）现在是FDA批准的第一个也是唯一一个可以提供每四周给药剂量的PD-1抑制剂

美国食品和药物管理局批准Opdivo标签更新，每两周（240毫克）或每四周（480毫克）提供灵活的平剂量选项1

Opdivo现在也批准了更短的30分钟输液，将之前的输液时间减半
2018年3月6日06:59 AM Eastern Standard Time

新泽西州普林斯顿 - （美国商业资讯） - 百时美施贵宝公司（纽约证券交易所代码：BMY）今天宣布，美国食品药品管理局（FDA）已批准补充生物制剂许可证申请（sBLA），更新Opdivo®（nivolumab）时间表包括每四周注射480毫克（Q4W）以满足大多数已批准的适应症的要求.1此批准将为医疗保健专业人员提供灵活性，以定制患者护理，并可选择使用新批准的Q4W（480 mg）平剂量到以前每隔两周（Q2W）的可用选项为240 mg，现在可在新的240 mg小瓶中使用.1 Opdivo也获准在所有批准的适应症中短时间内输注30分钟.1给药计划更新以获得额外的批准Opdivo的适应症可能会在未来提交给FDA。

    #MEDIA：美国食品及药物管理局批准了有史以来第一次灵活的两周或四周给予I-O代理商的剂量选择，用于选择适应症：
    鸣叫这个

“在百时美施贵宝，我们致力于从各个角度对抗癌症，并认识到每一位患者都有独特的需求。从我们第一个免疫肿瘤代理商的推出到今天批准灵活的剂量选择，每隔两到四周，我们就不遗余力地寻求癌症社区的创新选择，“布里斯托尔美国商业部负责人Johanna Mercier说。 Myers Squibb。 “通过这项批准，我们现在为免疫肿瘤药物提供最强大的剂量选择范围，提供更高的灵活性，以帮助满足每位患者的特定需求。”

百时美施贵宝公司在免疫肿瘤学方面的强大传统奠定了这一认可，该认证建立在该公司在开发使用人体自身免疫系统来帮助抗癌的药物开发上的经验。 Q4W（480 mg）平剂量选项已被批准用于Opdivo的以下适应症：

    转移性黑素瘤（用Yervoy®[ipilimumab]联合治疗后的单药治疗或单药治疗阶段）1,2
    先前治疗的转移性非小细胞肺癌1
    先前的抗血管生成治疗后的晚期肾细胞癌1
    以铂类为基础的化疗期间或之后的疾病进展之前治疗局部晚期或转移性尿路上皮癌1
    自体造血干细胞移植（HSCT）和brentuximab vedotin后复发/进展后的经典霍奇金淋巴瘤，或三系或更多系统系统治疗，包括自体HSCT1
    铂类治疗后头颈部复发/转移性鳞状细胞癌1
    索拉非尼治疗前的肝细胞癌1
    对伴有淋巴结转移或转移性疾病的完全切除的黑色素瘤患者进行辅助治疗1

Opdivo与以下警告和注意事项相关：免疫介导：肺炎，结肠炎，肝炎，内分泌病，肾炎和肾功能障碍，皮肤不良反应，脑炎等其他不良反应;输液反应; Opdivo之后的同种异体HSCT并发症;和胚胎 - 胎儿毒性

通过扩展标签，以下剂量计划选项立即可用：
  
时间表剂量
Q2W1 240毫克（现在有一瓶）1
Q4W1 480 mg1


“我们不断学习利用免疫肿瘤治疗来个性化治疗的新方法，根据我的经验，对于一名患者而言，有效的方法可能并不适用于另一名患者，”3 Jeffrey S. Weber医学博士，副主任纽约大学Langone健康中心的Perlmutter癌症中心和纽约大学医学院的医学教授。 “例如，有些患者可能需要支持为他们的医疗团队进行为期两周的访问，而对于其他患者而言，四周的间隔可能更适合并更适合他们的治疗需求.4通过此项批准，我们现在有了其他方法来帮助定制病人护理。“

适应症

OPDIVO®（nivolumab）作为单一药物用于治疗BRAF V600突变阳性不可切除或转移性黑素瘤患者。该指征基于无进展生存期的加速批准获得批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）作为单一药物用于治疗BRAF V600野生型不可切除或转移性黑素瘤患者。

OPDIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于治疗
OPVIVO®（nivolumab）与YERVOY®（ipilimumab）联合用于治疗不能切除或转移的黑色素瘤患者。该指征基于无进展生存期的加速批准获得批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）适用于治疗转移性非小细胞肺癌（NSCLC）的患者，铂类化疗期间或之后有进展。在接受OPDIVO之前，患有EGFR或ALK基因组肿瘤畸变的患者在FDA批准的这些畸变治疗中应该有疾病进展。

OPDIVO®（nivolumab）适用于先前接受过抗血管生成治疗的晚期肾细胞癌（RCC）患者的治疗。

OPDIVO®（nivolumab）适用于治疗成人自体造血干细胞移植（HSCT）和brentuximab vedotin复发或进展的经典霍奇金淋巴瘤（cHL）成人患者，或者3次或更多次全身治疗包括自体HSCT 。该指示基于整体响应速率在加速批准下获得批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）适用于在基于铂类药物治疗时或之后治疗患有头颈部复发或转移性鳞状细胞癌（SCCHN）的患者。

OPDIVO®（nivolumab）适用于治疗局部晚期或转移性尿路上皮癌患者，这些患者在含铂化疗期间或之后有疾病进展，或在含铂化疗的新辅助或辅助治疗12个月内有疾病进展。基于肿瘤应答率和应答持续时间的加速批准，该适应症获得批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）适用于治疗患有微卫星不稳定性高（MSI-H）或错配修复缺陷型（dMMR）转移性结直肠癌（CRC）的成人和儿科（12岁及以上）氟嘧啶，奥沙利铂和伊立替康。根据整体响应率和响应持续时间，该指示在加速批准下得到批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）适用于治疗之前接受过索拉非尼治疗的肝细胞癌（HCC）患者。该指征通过基于肿瘤响应率和响应耐久性的加速批准被批准。对这种适应症的持续批准可能取决于在验证性试验中对临床获益的验证和描述。

OPDIVO®（nivolumab）适用于黑色素瘤患者的辅助治疗，其中淋巴结转移或完全切除的转移性肿瘤患者。

OPDIVO®（10 mg / mL）是用于静脉注射（IV）的注射剂。

Hepbest

回复 StephenW 的帖子

这个不错，让HCC有最后的希望；

另外，中国国内也在参与到这个研究和临床中