LYNPARZA Has the Potential to Offer a New Treatment Option for Patients with Germline BRCA-Mutated, HER2-Negative Metastatic Breast Cancer
Regulatory Submission Acceptance Is the First for a PARP Inhibitor Beyond Ovarian Cancer
KENILWORTH, NJ, USA I October 18, 2017 I AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.
This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for LYNPARZA in the U.S. The sNDA is based on the positive results from the phase 3 OlympiAD trial published in the New England Journal of Medicine.
LYNPARZA was first approved under the FDA’s Accelerated Approval program in December 2014, as a capsule formulation, making it the first PARP inhibitor ever approved. Since then, more than 3,000 advanced ovarian cancer patients have been treated with LYNPARZA. LYNPARZA tablets are currently being tested in a range of tumor types, including breast, prostate and pancreatic cancers.
LYNPARZA tablets are currently approved in the U.S. as a maintenance treatment for adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. The medicine is also indicated for use in adult patients with deleterious or suspected deleterious gBRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy; patients for this indication are selected for therapy based on an FDA-approved companion diagnostic.
IMPORTANT SAFETY INFORMATION
DOSING AND ADMINISTRATION
To avoid substitution errors and overdose, do not substitute LYNPARZA (olaparib) tablets with LYNPARZA capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Recommended tablet dose is 300 mg, taken orally twice daily, with or without food. Continue treatment until disease progression or unacceptable toxicity. For adverse reactions, consider dose interruption or dose reduction.
About OlympiAD
OlympiAD is a randomized, open-label, multicenter phase 3 trial assessing the efficacy and safety of LYNPARZA (olaparib) tablets (300mg twice daily) compared to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international trial was conducted in 19 countries from across Europe, Asia, North America and South America.
About LYNPARZA® (olaparib)
LYNPARZA was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumor DNA damage response (DDR) pathway deficiencies to potentially kill cancer cells. Specifically, in vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.
LYNPARZA is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.
About Metastatic Breast Cancer
Approximately one in eight women are diagnosed with breast cancer in the U.S. Of these patients, approximately one-third are either diagnosed with or progress to the metastatic stage of the disease. Despite treatment options increasing during the past three decades, there is currently no cure for patients diagnosed with metastatic breast cancer. Thus, the primary aim of treatment is to slow progression of the disease for as long as possible, improving or at least maintaining, a patient’s quality of life.
About Germline BRCA Mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About the AstraZeneca and Merck Strategic Oncology Collaboration
On July 27, 2017, AstraZeneca and Merck & Co., Inc., announced a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib), the world’s first and leading PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. The collaboration is based on increasing evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumor types. Working together, the companies will jointly develop LYNPARZA and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 31
LYNPARZA Has the Potential to Offer a New Treatment Option for Patients with Germline BRCA-Mutated, HER2-Negative Metastatic Breast Cancer
Regulatory Submission Acceptance Is the First for a PARP Inhibitor Beyond Ovarian Cancer
KENILWORTH, NJ, USA I October 18, 2017 I AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a supplemental New Drug Application (sNDA) for the use of LYNPARZA® (olaparib) tablets in patients with germline BRCA-mutated (gBRCA), HER2-negative metastatic breast cancer (MBC) who have been previously treated with chemotherapy either in the neoadjuvant, adjuvant or metastatic settings. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2018.
This is the first submission for a poly ADP-ribose polymerase (PARP) inhibitor outside ovarian cancer and the third indication submission for LYNPARZA in the U.S. The sNDA is based on the positive results from the phase 3 OlympiAD trial published in the New England Journal of Medicine.
LYNPARZA was first approved under the FDA’s Accelerated Approval program in December 2014, as a capsule formulation, making it the first PARP inhibitor ever approved. Since then, more than 3,000 advanced ovarian cancer patients have been treated with LYNPARZA. LYNPARZA tablets are currently being tested in a range of tumor types, including breast, prostate and pancreatic cancers.
LYNPARZA tablets are currently approved in the U.S. as a maintenance treatment for adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy, regardless of BRCA status. The medicine is also indicated for use in adult patients with deleterious or suspected deleterious gBRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy; patients for this indication are selected for therapy based on an FDA-approved companion diagnostic.
IMPORTANT SAFETY INFORMATION
DOSING AND ADMINISTRATION
To avoid substitution errors and overdose, do not substitute LYNPARZA (olaparib) tablets with LYNPARZA capsules on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation. Recommended tablet dose is 300 mg, taken orally twice daily, with or without food. Continue treatment until disease progression or unacceptable toxicity. For adverse reactions, consider dose interruption or dose reduction.
About OlympiAD
OlympiAD is a randomized, open-label, multicenter phase 3 trial assessing the efficacy and safety of LYNPARZA (olaparib) tablets (300mg twice daily) compared to ‘physician’s choice’ chemotherapy (capecitabine, vinorelbine, eribulin) in 302 patients with HER2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations, which are predicted or suspected to be deleterious. The international trial was conducted in 19 countries from across Europe, Asia, North America and South America.
About LYNPARZA® (olaparib)
LYNPARZA was the first FDA-approved oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumor DNA damage response (DDR) pathway deficiencies to potentially kill cancer cells. Specifically, in vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death.
LYNPARZA is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DDR mechanisms in cancer cells.
About Metastatic Breast Cancer
Approximately one in eight women are diagnosed with breast cancer in the U.S. Of these patients, approximately one-third are either diagnosed with or progress to the metastatic stage of the disease. Despite treatment options increasing during the past three decades, there is currently no cure for patients diagnosed with metastatic breast cancer. Thus, the primary aim of treatment is to slow progression of the disease for as long as possible, improving or at least maintaining, a patient’s quality of life.
About Germline BRCA Mutations
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated, or altered, such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer.
About the AstraZeneca and Merck Strategic Oncology Collaboration
On July 27, 2017, AstraZeneca and Merck & Co., Inc., announced a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib), the world’s first and leading PARP inhibitor, and potential new medicine selumetinib, a MEK inhibitor, for multiple cancer types. The collaboration is based on increasing evidence that PARP and MEK inhibitors can be combined with PD-L1/PD-1 inhibitors for a range of tumor types. Working together, the companies will jointly develop LYNPARZA and selumetinib in combination with other potential new medicines and as a monotherapy. Independently, the companies will develop LYNPARZA and selumetinib in combination with their respective PD-L1 and PD-1 medicines.
Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.
As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the fastest-growing development programs in the industry. We are currently executing an expansive research program evaluating our anti-PD-1 therapy across more than 30 tumor types. We also continue to strengthen our immuno-oncology portfolio through strategic acquisitions and are prioritizing the development of several promising immunotherapeutic candidates with the potential to improve the treatment of advanced cancers.
For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck
For more than a century, Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
SOURCE: Merck
Post Views: 31
