Bayer Preps Filings For New Prostate Cancer Drug
If approved, will challenge Xtandi and Erleada
Armed with new phase 3 data, Bayer has said it intends to press ahead with regulatory filings for its anti-androgen drug darolutamide in early-stage prostate cancer.
The ARAMIS study tested the drugs ability to prevent locally-advanced, castration-resistant prostate cancer from spreading to other parts of the body, and showed that compared to placebo it significantly extended metastasis-free survival , defined as the time between the start of treatment and evidence of metastasis or death from any cause.
If approved, darolutamide would become the third anti-androgen therapy to be licensed for men with this stage of prostate cancer after Pfizer/AstellasXtandi and Johnson & Johnsons Erleada which both got the nod from regulators for non-metastatic CRPC earlier this year.
Bayer, which co-develops darolutamide with Finlands Orion Pharma under the terms of a 2014 licensing deal, says it will discuss the data from ARAMIS with regulatory authorities to see if the trial can support filings. It has picked up a fast-track designation for the drug from the FDA for non-metastatic CRPC.
While there are already two rivals on the market, darolutamides developers think it has qualities which could make it a good option for patients.
Under the terms of their 2014 agreement, Bayer has the right to commercialise darolutamide globally while Orion has an option to co-promote the product in Europe.
With This The German Drugmaker Seeks To Widen The Use Of The Prostate Cancer Drug From An Early Disease Stage To Metastatic Cases
Bayers Nubeqa drug won priority review status from the US Food and Drug Administration , as the German drugmaker seeks to widen the use of the prostate cancer drug from an early disease stage to metastatic cases.
The priority status was granted as the US regulatory body accepted Bayers supplemental New Drug Application for the use of Nubeqa, jointly developed with Finnish drugmaker Orion, against metastatic hormone-sensitive prostate cancer, Bayer said in a statement recently.
Edits by EP News Bureau
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Bayer Files For Expanded Use Of Prostate Cancer Drug Nubeqa In Us Eu
- Bayer submitted applications to the U.S. and EU drug regulators seeking approval of Nubeqa in combination with chemotherapy docetaxel in patients with metastatic hormone-sensitive prostate cancer .
- The German company filed a supplemental new drug application with the U.S. Food and Drug Administration and submitted a Variation Type II application to the European Medicines Agency .
- The filings are backed by data from a phase 3 trial called ARASENS which showed a statistically significant improvement in overall survival for Nubeqa plus androgen deprivation therapy and docetaxel in men with mHSPC.
- Bayer had raised peak sales expectation for Nubeqa following the late-stage study results.
- Nubeqa is developed jointly by Bayer and Finnish company Orion.
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An Evolving Standard Of Care
Hormone-sensitive prostate cancer means a patients tumors are still largely being fueled by male sex hormones called androgens. For many years, metastatic hormone-sensitive prostate cancer was treated with ADT alone, which blocks the production of androgens by the testicles.
In 2014, a large clinical trial showed that adding the chemotherapy drug docetaxel to ADT improved survival in men with metastatic hormone-sensitive prostate cancer. Since then, this combination has become the standard of care for this group of patients.
More recently, studies have shown that adding other drugs that block the production or binding of androgensincluding abiraterone , enzalutamide , and apalutamide to ADT also helps people with metastatic hormone-sensitive prostate cancer live longer. In a trial combining apalutamide with ADT, for example, approximately 82% of men were still alive after 2 years compared with 74% of men treated with ADT alone.
Several clinical trials were then launched to see if combining any of these drugs with ADT and docetaxel could build on those survival gains. Results of those studies, however, have been mixed, with one showing an improvement in survival without the disease progressing and another finding no increase in overall survival.
Cost And Ensuring Access
The cost of Nubeqa takes into account the clinical outcomes for patients and low side effect profile. The wholesale acquisition cost of Nubeqa is $11,550 for a 30-day supply of 300-mg tablets, Bayer said in an emailed statement to Healthline.
Cost can be an issue for many people, but Bayer also said theyre committed to ensuring that men in the United States who are prescribed Nubeqa will be able to access this medication and receive the support they need.
The company is launching a patient support program called Darolutamide User Drug Experience Access Services, which provides a free, two-month trial to eligible men and $0 co-pay for those who qualify and are commercially insured.
To learn more about these and other services, visit the website or call 1-833-337-DUDE Monday through Friday from 9:00 a.m. to 7:00 p.m. .
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Bayers Nubeqa Brings Quality Of Life Improvements In Prostate Cancer Group
German pharma major Bayer has added to the case for using Nubeqa to treat non-metastatic castration-resistant prostate cancer , for which the androgen receptor inhibitor was approved in the USA in 2019.
A post-hoc analysis of the Phase III ARAMIS trial that was presented at the 2021 AUA Annual Meeting showed Nubeqa was associated with delayed deterioration in patient quality of life related to urinary and bowel
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Nubeqa Allows Doctors More Flexibility To Treat Prostate Cancer
The ARAMIS trial was a randomized, phase III, multi-center, double-blind, placebo-controlled trial to evaluate the safety and efficacy of oral Nubeqa in men with nmCRPC being treated with androgen deprivation therapy who are at high risk for developing metastatic disease.
It involved 1,509 participants who were randomized to receive 600 milligrams of the oral drug twice a day, or a placebo, along with ADT.
With the approval of Nubeqa, we now have a new therapy that extends MFS and allows physicians greater flexibility to treat men with nmCRPC, Robert LaCaze, member of the executive committee of the pharmaceuticals division and head of the oncology strategic business unit at Bayer, said in a statement.
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About The Prostate Gland
The prostate gland is an inconspicuous organ the size of a walnut. Its primary function is to produce seminal fluid, which transports the male’s semen through the urethra. The prostate is also where the vas deferens and the ureter meet.
Detecting Prostate Cancer
Early prostate cancer usually does not cause symptoms, but more advanced cancers are sometimes detected because of symptoms they cause. Issues, and especially pain, during urination or ejaculation should be taken seriously. The same applies to a frequent urge to urinate, an inability to empty the bladder completely and finding blood in the semen or urine. That said, many of these symptoms are by no means a sure indication of cancer. They can also be caused by infections or by a benign enlargement of the prostate, which is very frequent. A urologist can give a precise diagnosis.
Most prostate cancers are diagnosed as a result of a screening blood test for prostate-specific antigen or a digital rectal exam. An elevated concentration of PSA can be the first sign of malignant disease in the prostate. Some guidelines recommend first undergoing a prostate MRI and, depending on the scoring of the MRI images, possibly a follow-up biopsy. Further tests, including other medical imaging, might be needed to support the exact diagnosis, staging and monitoring for patients with malignancy.
Treating Prostate Cancer
Sometimes, the above-mentioned therapies are combined.
Bayer Looks To Prostate Cancer Drug For Next Blockbuster
Bayer has high hopes of driving its prostate cancer drug into blockbuster status, meaning over $1 billion in annual sales. This week’s ARASENS trial results should help pave the road.
Already approved in non-metastatic castration-resistant prostate cancer, Nubeqa just proved its worth in metastatic hormone-sensitive prostate cancer too. In the trial, the drug improved overall survival for patients when administered in addition to standard of care, compared to those who received standard of care alone. Increased OS was the primary goal of the trial.
The standard of care in men with mHSPC is a hormone deprivation therapy with a strong chemo drug. Nubeqa comes alongside these treatments to attach to the androgen receptor on the prostate cells to block testosterone from connecting to it, thereby delaying cancer growth.
Men with metastatic prostate cancer have a dismal 30% 5-year survival rate. While the specific numbers have not been released, Bayer called the increased over all survival “significant.”
Nubeqa is also in a Phase III for men with mHSPC receiving ADT without the chemo. The trial hopes to prove radiological progression-free survival.
Full results of the ARASENS trial will be shared at an “upcoming meeting.”
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Chasing Rivals Bayer Files Nubeqa For New Prostate Cancer Use
Bayer has filed for approval to extend the use of its prostate cancer therapy Nubeqa as it tries to achieve labelling parity with rival drugs from Pfizer/Astellas and Johnson & Jonson, and fulfil its aim of 3 billion in peak sales for the drug.
Nubeqa is already making headway in the market as a treatment for non-metastatic, castration resistant prostate cancer , with sales of 219 million last year, but will need to expand into new forms of the disease if it is to meet its commercial objectives.
Part of that will be to include patients with metastatic, hormone-sensitive prostate cancer on the label, a group with more advanced disease that is already treated with blockbuster oral androgen receptor inhibitors like Pfizer/Astellas Xtandi and J& Js Erleada .
The latest filings for Nubeqa in the US and Europe are based on the ARASENS trial which showed that adding the drug to androgen deprivation therapy and docetaxel chemo led to a statistically significant improvement in overall survival compared to ADT plus docetaxel and placebo.
The risk of death was significantly lower by around 33% in the Nubeqa group compared to the placebo group, according to the results, which were in the New England Journal of Medicine in February.
There was also a big increase in the duration of response, from a media of just under 17 months to 41 months.
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Us Fda Accepts Supplemental New Drug Application And Grants Priority Review For Nubeqa In Combination With Docetaxel For Metastatic Hormone
Application is being reviewed concurrently among participating international health authorities under the FDA Oncology Center of Excellence’s Project Orbis initiative
WHIPPANY, N.J., May 03, 2022—-Bayer today announced the U.S. Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for the oral androgen receptor inhibitor NUBEQA® in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer .
The sNDA is based on positive results from the investigational Phase III ARASENS trial demonstrating a statistically significant improvement in overall survival for NUBEQA plus androgen deprivation therapy and docetaxel in men with mHSPC compared to ADT plus docetaxel, which were published in The New England Journal of Medicine.1 NUBEQA is currently indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer .
“Bayer remains dedicated to addressing unmet needs in prostate cancer treatment for various stages of the disease,” said Christine Roth, Member of the Executive Committee of Bayers Pharmaceutical Division and Head of the Oncology SBU at Bayer. “Todays sNDA acceptance, confirmation of Priority Review and participation in Project Orbis, bring us closer to adding a new indication for NUBEQA in combination with docetaxel to benefit men with mHSPC.”
About the ARASENS Trial2
About NUBEQA® 3
IMPORTANT SAFETY INFORMATION FOR NUBEQA®
A New Option For Men With Prostate Cancer
Patients at this stage of prostate cancer typically dont have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy, Matthew Smith, MD, PhD, director of the genitourinary malignancies program at Massachusetts General Hospital Cancer Center in Boston, said in a statement.
This approval marks an important new option for the prostate cancer community, he said.
Nubeqa was approved under the Agencys
More Options Lead To More Questions
Elisabeth Heath, M.D., director of prostate cancer research at Karmanos Cancer Institute in Detroit, agreed that the ARASENS results should have an immediate impact on how this form of the disease is treated.
Speaking at the ASCO symposium, Dr. Heath, who was not involved in the study, highlighted an important difference between ARASENS and other trials that tested androgen receptorblocking drugs in men with this form of prostate cancer. In those other trials, she explained, some participants received docetaxel prior to treatment with the androgen receptorblocking drugs rather than at the same time.
Based on the ARASENS results, Dr. Heath said, giving all three treatments simultaneously looks to be the preferred option for some patients.
Dr. Karzai noted that despite there being multiple options to treat metastatic hormone-sensitive prostate cancer, many questions remain. We don’t have guidelines on who should start with what drug and whether one drug is better than another for a patient, she said.
She also pointed out that more research is needed on how the order in which the drugs are given impact their effectiveness and the frequency of side effects.
Additionally, she said, the survival improvement in the ARASENS trial was seen in patients whose cancer had spread in multiple areas beyond the prostate .
We dont know if people with lower-volume benefit from as much as the patients with higher-volume disease do, she said.
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Bayer Triples Sales Forecast For Prostate Cancer Drug Nubeqa
Bayer now says it expects to make 3 billion in sales for its prostate cancer treatment Nubeqa, up from an earlier estimate of 1 billion, after reviewing new data for the drug in metastatic hormone-sensitive tumours.
The optimistic assessment of the revenue potential for androgen receptor inhibitor Nubeqa follows the publication of the results of the phase 3 ARASENS trial in the New England Journal of Medicine.
The study showed that adding Nubeqa to standard therapy with anti-androgen drugs and chemotherapy with docetaxel reduced the risk of dying by 32.5% compared to standard therapy alone. There was also a big increase in the duration of response, from a media of just under 17 months to 41 months.
The data will be filed with regulatory authorities to seek an expansion of the label for Nubeqa, according to Bayer, which developed Nubeqa in collaboration with Finlands Orion.
The drug is already approved to treat non-metastatic castration-resistant prostate cancer , but expansion into hormone-sensitive prostate cancer could unlock a sizeable new market for the drug.
That would allow Nubeqa to try to claim market share from other more established drugs in the oral androgen receptor inhibitor class, including Johnson & Johnsons Erleada and Pfizer/Astellas Xtandi , although analysts have suggested that could be a tough proposition as physicians have more experience with the current drugs.
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Prostate Cancer Treatment: Competition
After Xtandi and Erleada, darolutamide is the third in a line of second-generation anti-androgen hormonal therapies to seek approval for nmCRPC patients. Depending on the market, these drugs are also used to treat other patient subsets, including those with metastatic hormone-sensitive, nonmetastatic castration-resistant, and metastatic castration-resistant prostate cancer .
To provide insight on the near-term nmCRPC segment in the three geographic markets, it was estimated that darolutamide will capture the smallest market share by sales among its competitors by the end of the 20162026 forecast period.
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Fda Approves Bayers Nubeqa A New Treatment For Men With Non
WHIPPANY, N.J., July 30, 2019 /PRNewswire/ The U.S. Food and Drug Administration today approved Nubeqa® , an androgen receptor inhibitor , for the treatment of patients with non-metastatic castration-resistant prostate cancer . The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy , which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival , with a median of 40.4 months versus 18.4 months for placebo plus ADT . MFS is defined as the time from randomization to the time of first evidence of blinded independent central review -confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDAs Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.
Patients at this stage of prostate cancer typically dont have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy, said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. This approval marks an important new option for the prostate cancer community.
For additional information, please visit Bayer Website.