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New Drug Prostate Cancer Approved Fda

Remission And The Chance Of Recurrence

New prostate cancer tracer approved by FDA

A remission is when cancer cannot be detected in the body and there are no symptoms. This may also be called having no evidence of disease or NED.

A remission can be temporary or permanent. This uncertainty causes many people to worry that the cancer will come back. Although there are treatments to help prevent a recurrence, such as hormonal therapy and radiation therapy, it is important to talk with your doctor about the possibility of the cancer returning. There are tools your doctor can use, called nomograms, to estimate someone’s risk of recurrence. Understanding your risk of recurrence and the treatment options may help you feel more prepared if the cancer does return. Learn more about coping with the fear of recurrence.

In general, following surgery or radiation therapy, the PSA level in the blood usually drops. If the PSA level starts to rise again, it may be a sign that the cancer has come back. If the cancer returns after the original treatment, it is called recurrent cancer.

When this occurs, a new cycle of testing will begin again to learn as much as possible about the recurrence, including where the recurrence is located. The cancer may come back in the prostate , in the tissues or lymph nodes near the prostate , or in another part of the body, such as the bones, lungs, or liver . Sometimes the doctor cannot find a tumor even though the PSA level has increased. This is known as a PSA-only or biochemical recurrence.

Joining The Resistance: New Prostate Cancer Target Could Reactivate Standard Of Care Treatments

Current standard-of-care hormone therapy can only go so far in treating metastatic prostate cancer until the body develops resistance, but new research from the Cleveland Clinic suggests a new pathway that could make tumors respond to treatments once again.

Cleveland Clinic has discovered a new drug target that reduced the size of tumors and improved survival in mice with drug-resistant prostate cancer. The findings, published today in Science Translational Medicine, also suggest potential for use in humans after research was conducted on biopsied patient tumors.

The current standard of care for this type of prostate cancer is Xtandi, made by Astellas and Pfizer. The drug, also known as enzalutamide, blocks the proteins that help drive cancer cells known as androgen receptors. This is effective at first, but most patients eventually form resistance to the treatment because cancer cells adapt and get a boost from the glucocorticoid receptor, a similar receptor to androgen.

These glucocorticoid receptors bind to and interact with cortisol, the stress hormone, causing an increase in tumor cortisol levels that has been linked to Xtandi resistance. When the protein 11-HSD2 is inhibited in some tumors, cancer cells take advantage of the cortisol and glucocorticoid receptors.

Fda Approves First Oral Hormone Therapy For Treating Advanced Prostate Cancer

Today, the U.S. Food and Drug Administration approved relugolix for the treatment of adult patients with advanced prostate cancer.

Todays approval marks the first oral drug in this class and it may eliminate some patients need to visit the clinic for treatments that require administration by a health-care provider, said Richard Pazdur, MD, Director of the FDAs Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDAs Center for Drug Evaluation and Research. This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.

The American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the United States. One of the treatment options for advanced prostate cancer is androgen-deprivation therapy, which uses drugs to lower levels of the hormones that help prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Relugolix is an orally administered gonadotropin-releasing hormone receptor antagonist that works by blocking the pituitary gland from producing luteinizing hormone and follicle-stimulating hormone, thereby reducing the amount of testosterone the testicles are able to make.

Clinical Trial

Adverse Events

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Newly Approved Prostate Cancer Scan Can Detect Cells That Have Spread To Lymph Nodes

Thomas Hope , MD, and Peter Carroll, MD, stand at the PACS workstation where the images from the PSMA PETs are viewed and interpreted. The imaging technique received FDA approval in 2020.

A revolutionary new diagnostic method for prostate cancer can detect prostate cancer cells that have spread to lymph nodes both inside and outside the pelvis, according to the UC San Francisco and UCLA team whose earlier work led to the tests FDA approval.

The test, which is now available at UCSF and UCLA, makes cancer cells light up on positron emission tomography with a radioactive compound developed more than a decade ago in Germany. The method, known as PSMA PET imaging, should become more widely available as commercial firms enter the market.

This is a game changer, said Peter Carroll, MD, MPH, professor in the UCSF Department of Urology and a senior researcher for the study. It will lead to more refined treatment for men with high-risk prostate cancer at the time of diagnosis, as well as for previously treated men whose cancers recur.

The key to this improved PET imaging approach is an injectable formulation containing a small amount of Gallium 68 PSMA-11. Within the body the diagnostic agent attaches to a protein called the prostate-specific membrane antigen , which is abundant on prostate cells that are cancerous, but not on normal tissue. Gallium 68 PSMA-11 emits positron particles detectible with PET imaging, highlighting tissue to which cancer has spread.

Fda Approves First Commercially Available Psma Pet Imaging Agent For Prostate Cancer

FDA Approves New Therapy for Advanced Prostate Cancer ...

Image courtesy of JNM

June 28, 2021 The U.S. Food and Drug Administration approved a new imaging agent for detection of prostate cancer, providing a more effective imaging approach to detect the spread of cancer to other parts of the body. Piflufolastat F-18 injection is the first fluorinated prostate-specific membrane antigen agent approved by the FDA and also the first commercially available PSMA PET imaging agent.

The agent is approved for PET imaging of PSMA-positive lesions in men with prostate cancer

  • with suspected metastasis who are candidates for initial definitive therapy or
  • with suspected recurrence based on elevated serum prostate-specific antigen level.

We believe todays approval is a game-changer for men facing prostate cancer, said Jamie Bearse, Chief Executive Officer of ZERO The End of Prostate Cancer, a patient advocacy group. Having a diagnostic tool that allows doctors to see suspected metastatic or recurrent prostate cancer earlier, anywhere in the body, is a significant step forward and will have a tremendous impact on patients lives.

The agent is manufactured by Lantheus as Pylarify injection and will be widely available throughout the United States.

For more information:

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Innovation: Frequent Use Of Expedited Development And Review Pathways

CDER used several regulatory pathways to enhance efficiency and expedite the development and approval of novel drugs in 2020. These pathways use a range of approaches, including more interactions between CDER staff and drug developers, greater program design flexibility, and shortened timelines for review of applications.

Fast Track

Fast Track-designated drugs have the potential to address unmet medical needs. CDER designated 17 of the 53 novel drugs in 2020 as Fast Track. Fast Track speeds new drug development and review by increasing the level of communication between FDA and drug developers, and by enabling CDER to review portions of a drug application ahead of the submission of the complete application.

Drugs designated with Fast Track status were: artesunate, Ayvakit, Detectnet, Dojolvi, Enspryng, Evrysdi, Margenza, Monjuvi, Olinvyk, Orladeyo, Qinlock, Rukobia, Tepezza, Trodelvy, Tukysa, Veklury, and Viltepso.

Breakthrough Therapy

Drugs designated with Breakthrough therapy status were: artesunate, Ayvakit, Blenrep, Danyelza, Ebanga, Enspryng, Gavreto, Imcivree, Inmazeb, Koselugo, Monjuvi, Oxlumo, Pemazyre, Qinlock, Retevmo, Rukobia, Tabrecta, Tepezza, Trodelvy, Tukysa, Uplizna, and Zokinvy.

Priority Review

Accelerated Approval

The Novel drug approved in 2020 that received the Accelerated Approval designation were: Blenrep, Danyelza, Gavreto, Lampit, Monjuvi, Pemazyre, Retevmo, Tabrecta, Tazverik, Trodelvy, Viltepso, and Zepzelca.

Impact Of Novel Drug Approvals

Many of the novel drugs CDER approved in 2020 are notable for their potential positive impact and unique contributions to quality medical care and patient treatment.


CDER identified 21 of the 53 novel drugs approved in 2020 as first-in-class, which is one indicator of the drugs potential for strong positive impact on the health of the American people. These drugs often have mechanisms of action different from those of existing therapies.

Examples of notable First-in-Class novel approvals for 2020 include:

  • Rukobia , tablets, a new type of antiretroviral medication for adults living with HIV-1 who have tried multiple HIV-1 medications and whose HIV-1 infection cannot be successfully treated with other therapies because of resistance, intolerance, or safety considerations. This approval marks a new class of antiretroviral medications that may benefit patients who have run out of HIV-1 treatment options.
  • Koselugo , capsules, for the treatment of certain pediatric patients, two years of age and older, with neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves. This is the first drug approved by the FDA to treat this debilitating, progressive, and often disfiguring disease that typically begins early in life.

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Autoimmune Inflammatory And Lung Diseases

In 2020, CDER approved two new therapies for the treatment of polyarticular juvenile idiopathic arthritis, a type of juvenile arthritis that causes inflammation in five or more joints within the first six months of the disease. CDER also approved a new therapy for pediatric patients with ulcerative colitis, a chronic disease of the large intestine, in which the lining of the colon becomes inflamed and develops open sores, or ulcers. Additionally, CDER approved a new therapy to treat patients with chronic fibrosing interstitial lung diseases with a progressive phenotype the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

Notable approvals for patients with rare diseases include:

Nightly Newsal Roker Shares Prostate Cancer Diagnosis And Encourages Early Screening

FDA Approval in AML, Priority Review in Prostate Cancer, EMA CHMP Recommendations, and More

The new technique uses a tracer molecule that seeks out a protein found on most prostate cancer cells called prostate-specific membrane antigen, or PSMA. The tracer, which is injected into the bloodstream, lights up those cells during a PET scan.

A similar tracing agent, which also seeks out PSMA, was approved by the FDA in December for use at two California hospitals: the University of California, Los Angeles and the University of California, San Francisco. The facilities had been researching this kind of technology since 2015.

“We’ve been using it for many years and it works great,” said Dr. Thomas Hope, director of molecular therapy in UCSF’s Department of Radiology and Biomedical Imaging. “We can actually see where the disease is and now people are getting targeted radiation.”

“It’s redefining how we think about prostate cancer,” he said.

The new approval will be the first such tracer for advanced prostate cancer commercially available nationwide.

The scan isn’t meant to replace PSA testing, a common prostate cancer screening tool. PSA stands for prostate-specific antigen, a protein found in the blood. Instead, it’s meant for men who have already been diagnosed with the disease.

While Wei and other prostate cancer experts agreed that the imaging would give them more information about metastatic cancer, it remains unclear what they should do with the information.

And not all metastatic prostate cancers will threaten a man’s life.

Read Also: How To Read A Bone Scan For Prostate Cancer

Newer Treatments For Early

Researchers are looking at newer forms of treatment for early-stage prostate cancer. These new treatments could be used either as the first type of treatment or after unsuccessful radiation therapy.

One treatment, known as high-intensity focused ultrasound , destroys cancer cells by heating them with highly focused ultrasonic beams. This treatment has been used in some countries for a while, and is now available in the United States. Its safety and effectiveness are now being studied, although most doctors in the US dont consider it to be a proven first-line treatment for prostate cancer at this time.

Two Agents Approved For Psma

On May 26, FDA approved piflufolastat F 18 for use in a type of imaging procedure called PSMA PET in people with prostate cancer. The approval covers the use of piflufolastat F 18 in patients suspected of having metastatic prostate cancer or recurrent prostate cancer . Last year, the agency approved another imaging agent for PSMA PET, Ga 68 PSMA-11, for the same uses, but its use is largely limited to the two institutions where it is made.

In a statement, Lantheus, which manufactures piflufolastat F 18, said the imaging agent will be immediately available in parts of the mid-Atlantic and southern regions with broad availability across the U.S. anticipated by year end.

PSMA is often overproduced by prostate cancer cells but is generally not produced by most normal cells, making it an excellent target for both PET imaging and targeted systemic radiation therapy like 177Lu-PSMA-617, Dr. Morris said.

Read Also: What Is Localized Prostate Cancer

Access: First Cycle Approval And Approvals Compared To Other Countries

First Cycle Approval

CDER approved 49 of the 53 novel drugs of 2020 on the first cycle of review, meaning without a complete response letter from FDA that requires re-submission with additional information, resulting in a delay to approval. From 2011 through 2019, CDER approved 357 novel drugs, of which 304 were approved on the first cycle. This high proportion of first-cycle approval reflects the extent to which CDER staff and drug developers work together to ensure that the studies supporting approval are well designed and that the application contains the information CDER needs to be able to fully review, and if appropriate, approve an application.

First cycle approval prevents delays in bringing valuable new therapies to market.

artesunate, Ayvakit, Blenrep, Byfavo, Cerianna, Danyelza, Detectnet, Dojolvi, Ebanga, Enspryng, Evrysdi, Ga 68 PSMA-11, Gavreto, Gemtesa, Imcivree, Inmazeb, Inqovi, Isturisa, Klisyri, Koselugo, Lampit, Margenza, Monjuvi, Nexletol, Nurtec ODT, Ongentys, Orgovyx, Orladeyo, Oxlumo, Pemazyre, Pizensy, Qinlock, Retevmo, Rukobia, Sarclisa, Sogroya, Tabrecta, Tauvid, Tazverik, Tepezza, Tukysa, Uplizna, Veklury, Viltepso, Vyepti, Winlevi, Zeposia, Zepzelca, and Zokinvy.

Approval in the U.S. Before Other Countries

Although regulatory processes differ widely between FDA and those of regulatory agencies in other countries, 40 of the 53 novel drugs approved in 2020 were approved in the U.S. before receiving approval in any other country.

Active Surveillance And Watchful Waiting

New drug gives hope to prostate cancer patients

If prostate cancer is in an early stage, is growing slowly, and treating the cancer would cause more problems than the disease itself, a doctor may recommend active surveillance or watchful waiting.

Active surveillance. Prostate cancer treatments may seriously affect a person’s quality of life. These treatments can cause side effects, such as erectile dysfunction, which is when someone is unable to get and maintain an erection, and incontinence, which is when a person cannot control their urine flow or bowel function. In addition, many prostate cancers grow slowly and cause no symptoms or problems. For this reason, many people may consider delaying cancer treatment rather than starting treatment right away. This is called active surveillance. During active surveillance, the cancer is closely monitored for signs that it is worsening. If the cancer is found to be worsening, treatment will begin.

ASCO encourages the following testing schedule for active surveillance:

  • A PSA test every 3 to 6 months

  • A DRE at least once every year

  • Another prostate biopsy within 6 to 12 months, then a biopsy at least every 2 to 5 years

Treatment should begin if the results of the tests done during active surveillance show signs of the cancer becoming more aggressive or spreading, if the cancer causes pain, or if the cancer blocks the urinary tract.

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Improved Testosterone Suppression Lower Cardiac Risks

More than 900 men with advanced prostate cancer whose tumors still relied on testosterone were enrolled in the HERO trial, which was funded by Myovant Sciences, the manufacturer of relugolix.

Participants were assigned at random to take relugolix daily for 48 weeks or to receive leuprolide injections every 3 months for the same length of time.

Approximately 97% of men treated with relugolix reached and maintained very low testosterone levels through 48 weeks, compared with 89% of men who received leuprolide. In addition, men in the relugolix group also did substantially better on several other measures, including being able to return to normal testosterone levels within a few months of stopping therapy.

The latter finding is very important, Dr. Shore said. Suppressing testosterone for long periods can lead to significant side effects, he explained, including fatigue, hot flashes, and bone problems. And in clinical practice, ADT might only be used for short periods, such as when its being given along with radiation therapy.

So if your testosterone level returns to normal values faster after stopping ADT, that to me is a real positive, he said.

When the HERO trial investigators looked specifically at men who had a history of heart problems, the difference in the frequency of these cardiac side effects was even more stark: 17.8% in the leuprolide group versus 3.6% in the relugolix group.

Fda Approves New Prostate Cancer

One out of every eight men will get prostate cancer.

Itâs the second most common type of cancer in men, and itâs a type of cancer researchers are working vigorously to get ahead of.

What You Need To Know

  • FDA approved a new drug to help doctors detect prostate cancer
  • Studies showed 92% accuracy, Moffitt radiologist says
  • Previous methods were 65% accurate

âThe number of people we can actually help, itâs immense. Itâs truly different. We havenât had something like this for a long, long time,â said Dr. Kenneth Gage, a radiologist at Moffitt Cancer Center.

He reads scans of prostate cancer patients almost daily and helped recruit people for this latest trial that he calls revolutionary, especially for people who have more advanced disease.

âThis is really going to help us clarify for a lot of patients the best way forward,â Dr. Gage told Spectrum News.

A prostate specific membrane antigen, also known as a PSMA â or by its commercial name, Pylarify â is injected into the patient.

The injection agent is designed to find its way to cancer cells in the prostate. Doctors can then use a PET scan of the prostate to detect precisely where the cancer cells are located.

He explained that the trial showed the PSMA revealed prostate cancer with 92% accuracy â a significant improvement over the 65% accuracy without it.

Dr. Gage said doctors can use this information to determine the best possible treatment plan

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