Merck Bladder Cancer Treatment BAVENCIO Gets USFDA Approval
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BAVENCIO (avelumab) for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy.
Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,3,4 and only 5% of patients with metastatic disease at diagnosis will live longer than five years. "Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer," said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network. "We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope."
or patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity. The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval. "Today's approval of BAVENCIO in the most common type of advanced bladder cancer underscores our commitment to advancing scientific innovation and transforming outcomes for people with genitourinary cancers," said Andy Schmeltz, Global President, Pfizer Oncology. "With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice," said Rehan Verjee, President, EMD Serono and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck KGaA, Darmstadt, Germany.
The alliance is committed to providing patient access and reimbursement support through its CoverOne program to patients who have been prescribed BAVENCIO. This program provides a spectrum of patient access and reimbursement support services intended to help US patients prescribed BAVENCIO receive appropriate access. BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC 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. BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC). In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment. BAVENCIO Important Safety Information from the US FDA-Approved Label BAVENCIO can cause immune-mediated pneumonitis, including fatal cases.
Platinum-based chemotherapy is currently the first-line standard of care for eligible patients with advanced disease based on high initial response rates. However, most patients will ultimately experience disease progression within nine months of initiation of treatment,3,4 and only 5% of patients with metastatic disease at diagnosis will live longer than five years. "Many patients newly diagnosed with advanced urothelial carcinoma receive benefit from initial chemotherapy, but we still need treatment options that can help patients live longer," said Andrea Maddox-Smith, CEO of the Bladder Cancer Advocacy Network. "We wholeheartedly support the development of new and promising treatments like BAVENCIO that can offer patients and their loved ones hope."
or patients that do not progress on platinum-containing chemotherapy, BAVENCIO is administered as a first-line maintenance treatment until disease progression or unacceptable toxicity. The FDA previously approved BAVENCIO under the accelerated approval program in 2017 for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy, based on tumor response rate and duration of response. Continued approval was contingent upon verification of clinical benefit, which was demonstrated in JAVELIN Bladder 100. The FDA has now converted the accelerated approval to full approval. "Today's approval of BAVENCIO in the most common type of advanced bladder cancer underscores our commitment to advancing scientific innovation and transforming outcomes for people with genitourinary cancers," said Andy Schmeltz, Global President, Pfizer Oncology. "With this approval for BAVENCIO, we have the opportunity to fundamentally shift the standard of care in the first-line setting of advanced bladder cancer. Our focus now is to work closely with the GU community to ensure that this novel and potentially life-changing treatment paradigm is rapidly integrated into clinical practice," said Rehan Verjee, President, EMD Serono and Global Head of Innovative Medicine Franchises for the Biopharma business of Merck KGaA, Darmstadt, Germany.
The alliance is committed to providing patient access and reimbursement support through its CoverOne program to patients who have been prescribed BAVENCIO. This program provides a spectrum of patient access and reimbursement support services intended to help US patients prescribed BAVENCIO receive appropriate access. BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.BAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC 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. BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC). In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment. BAVENCIO Important Safety Information from the US FDA-Approved Label BAVENCIO can cause immune-mediated pneumonitis, including fatal cases.
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