Amgen, Allergan, BMS, and Takeda Lead Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Amgen, Allergan, BMS, and Takeda.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday January 17, 2018 date to Tuesday January 23, 2018.

EC OKs Amgen’s, Allergan’s Biosimilar of Roche’s Cancer Drug Avastin
The European Commission (EC) has granted Amgen and Allergan marketing authorization for Mvasi (bevacizumab), a biosimilar to Roche’s Avastin (bevacizumab), for treating several types of cancer. Avastin had 2016 global sales of CHF 6.78 billion ($7.04 billion).

In September 2017, Mvasi became the first anti-cancer biosimilar, as well as the first biosimilar bevacizumab, to be approved by the US Food and Drug Administration, according to information from the FDA. Amgen and Allergan have been collaborating on the development and commercialization of four oncology biosimilars since 2011. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the EC. One is Mvasi and the other is Amgevita (adalimumab), a biosimilar to AbbVie’s Humira (adalimumab), which was approved in April 2017.

Approval from the EC grants a centralized marketing authorization with unified labeling in the 28 countries that are members of the European Union. Norway, Iceland, and Liechtenstein, as members of the European Economic Area, will take corresponding decisions on the basis of the decision of the EC.

In the European Union, Mvasi is indicated:

  • in combination with fluoropyrimidine-based chemotherapy, for treating adult patients with metastatic carcinoma of the colon or rectum.
  • in combination with paclitaxel, for first-line treatment of adult patients with metastatic breast cancer.
  • in addition to platinum-based chemotherapy, for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) other than predominantly squamous cell histology.
  • in combination with erlotinib, for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous NSCLC with epidermal growth factor receptor (EGFR) activating mutations.
  • in combination with interferon alfa-2a, for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer.
  • in combination with carboplatin and paclitaxel, for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, for treating adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
  • in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin, for treating adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
  • in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, for treating adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.

Mvasi is indicated in the US for treating:

  • metastatic colorectal cancer (mCRC) with intravenous 5-fluorouracil–based chemotherapy for first- or second-line treatment.
  • mCRC, with fluoropyrimidine- irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab-containing regimen. MVASI is not indicated for adjuvant treatment of colon cancer.
  • non-squamous NSCLC, with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • glioblastoma, as a single agent for adult patients with progressive disease following prior therapy.
  • metastatic renal cell carcinoma with interferon alfa.
  • cervical cancer, in combination with paclitaxel and cisplatin or paclitaxel and topotecan in persistent, recurrent, or metastatic disease.

Source: Amgen


EC OKs BMS’s Melanoma Drug Yervoy for Pediatric Use
The European Commission (EC) has expanded the indication of Bristol-Myers Squibb’s (BMS) Yervoy (ipilimumab), a drug for treating melanoma, to include treatment of advanced (unresectable or metastatic) melanoma in pediatric patients 12 years of age and older.

The EC approval allows for the marketing of Yervoy for this indication in all 28 member states of the European Union. Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4, which is a negative regulator of T-cell activity, according to information from the company.

The US Food and Drug Administration (FDA) approved Yervoy to treat pediatric patients 12 years and older with unresectable or metastatic melanoma in July 2017.

The FDA approved Yervoy in 2011 to treat unresectable or metastatic melanoma. Yervoy is now approved for unresectable or metastatic melanoma in more than 50 countries. It is also indicated for the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy. The company has a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

Source: Bristol-Myers Squibb


EC Approves New Use for Takeda’s Cancer Drug Adcetris
The European Commission (EC) has approved a new use for Takeda Pharmaceutical Company’s Adcetris (brentuximab vedotin), an antibody-drug conjugate (ADC) for treating adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

Adcetris is an ADC directed at CD30, which is expressed on skin lesions in approximately 50% of patients with CTCL, according to information from Takeda.

Adcetris received conditional marketing authorization from the EC for three other indications: (1) treating adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option; (2) treating adult patients with relapsed or refractory systemic anaplastic large cell lymphoma; and (3) treating adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

Takeda and Seattle Genetics, a Bothell, Washington-headquartered biotechnology company, are jointly developing Adcetris. Under the agreement, Seattle Genetics has US and Canadian commercialization rights, and Takeda has rights to commercialize the drug in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for Adcetris on a 50:50 basis, except in Japan, where Takeda is solely responsible for development costs.

Source: Takeda Pharmaceutical Company

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