A new hormonal therapy for prostate cancer is under expedited FDA review

In June, the US Food and Drug Administration (FDA) launched an accelerated review of a promising new drug for advanced prostate cancer. Called relugolix, it suppresses testosterone and other hormones that speed the cancer’s growth. If approved, this new type of hormonal therapy is expected to set a new standard of care for the disease. […] The post A new hormonal therapy for prostate cancer is under expedited FDA review appeared first on Harvard Health Blog.

A new hormonal therapy for prostate cancer is under expedited FDA review

In June, the US Food and Drug Administration (FDA) launched an accelerated review of a promising new drug for advanced prostate cancer. Called relugolix, it suppresses testosterone and other hormones that speed the cancer’s growth. If approved, this new type of hormonal therapy is expected to set a new standard of care for the disease.

Doctors give hormonal therapies when a man’s tumor is metastasizing (spreading beyond the prostate), or if his PSA levels start rising after surgery or radiation. The most commonly used hormonal therapies, called LHRH agonists, will eventually lower testosterone levels in blood. But that decline happens only after testosterone flares up to high levels as an initial response to treatment. This short-term flare-up, which lasts about a month, can cause bone pain, urinary obstruction, and other symptoms. So, doctors will ordinarily give LHRH agonists together with other drugs that prevent testosterone from interacting with cells in the body.

Alternatively, men can be treated with a different class of hormonal therapies that lower testosterone levels without the initial flare. These drugs are known as GnRH antagonists, and only one is currently available in the United States. Called degarelix, it’s given once a month by injections that can in some instances cause pain, redness, and swelling. (A different injectable GnRH antagonist, called abarelix, was withdrawn from US markets in 2005 after it caused a higher-than-expected increase in allergic reactions.)

Needle-free

Here is where relugolix enters the picture: it’s also a GnRH antagonist, but rather than being given by monthly injections, it’s taken as a daily pill.

The FDA was prompted to speed the drug’s review based on its superior performance during a late-stage clinical trial. The study investigators enrolled 934 men from 155 hospitals in the United States and Japan. Half the men had elevated PSA levels after having been treated already for prostate cancer. The rest had newly diagnosed metastatic cancer, or more localized prostate tumors that weren’t suitable for surgery. A total of 622 were treated with relugolix, and 305 men were given an LHRH agonist called leuprolide. All the men were treated for 48 weeks.

By all measures, relugolix came out ahead. The drug lowered testosterone to acceptable therapeutic levels within four days, whereas in the leuprolide-treated men, testosterone initially surged to an average of more than ten times the target concentration before dropping below it 29 days later. Furthermore, normal testosterone levels were restored within 90 days after relugolix treatment was discontinued. By contrast, just 3% of the leuprolide-treated men achieved normal testosterone levels within that same duration after treatment. That testosterone levels go back to normal after hormonal therapy is important for quality of life, including among men who receive the treatment intermittently.

Dr. Marc Garnick, Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor in chief of HarvardProstateKnowledge.org, points out that relugolix also had a better safety profile for measures of heart health. It’s long been known that hormonal therapy in general can have cardiac toxicities, especially among men with pre-existing risk factors such as diabetes, hypertension, or a prior heart attack. But during this clinical trial, fewer men in the relugolix group experienced significant cardiac side effects after 48 weeks of treatment.

“This is an important study, as it demonstrates the ability of a GnRH antagonist to be administered as an oral drug,” Garnick said. “The continued development of GnRH antagonists has many advantages compared to drugs that require an obligatory increase in testosterone before achieving their desired effects. The oral availability of relugolix may also lessen some of the local skin reactions that are common with degarelix, or some of the allergic reactions that occurred with abarelix.”

The FDA is expected to make a decision on the drug’s approval by December 20, 2020.

Disclosure: Dr. Garnick has been named as a scientific advisor to Myovant Sciences (the developer of relugolix) and is a shareholder in the company. He was also a developer of abarelix and previously served as an advisor to Ferring Pharmaceuticals, the developer of degarelix.

The post A new hormonal therapy for prostate cancer is under expedited FDA review appeared first on Harvard Health Blog.

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Breastfeeding troubles? There’s help

Low milk production and painful latching can sometimes lead to difficulties for nursing moms.

Breastfeeding troubles? There’s help
By logging breastfeeding behaviors, you’ll get a better sense of how much breast milk your little one is consuming. (For Spectrum Health Beat)

The moment you find out you’re having a baby, it opens a floodgate of questions.

Will it be a girl or a boy? Is there anything I should or shouldn’t eat? When should I start buying maternity clothes? What happens at labor and delivery?

At some point you’ll also need to think about breastfeeding or formula feeding.

We’ve looked in other stories at several great things about the benefits of breastfeeding for both mom and baby, such as the many health benefits and positive effects on baby’s brain health.

And even though we know breastfeeding leads to all these great things, some moms may stop breastfeeding early.

There are two primary reasons moms will stop breastfeeding: lack of milk production and presence of pain.

One study involving more than 1,300 moms found that about half the participating moms cited insufficient milk supply as a reason to stop breastfeeding.

The other reason? Pain when nursing or pain when the baby latched on.

Let’s take a look at these reasons.

Low milk production

I hear this from moms fairly frequently.

I think one thing at work here is the visual feedback from bottles. When we offer a baby a bottle, we can see how much formula is in the bottle—and we can physically see how much the baby ingested once they’re done.

With breastfeeding, you can’t necessarily see the amount of breastmilk consumed. It’s easy to then wonder, “Did I make enough milk?” or, “Is my baby getting enough?”

So how do you know? At any Spectrum Health hospital, you’ll receive a feeding log to help you keep track of how often your baby is nursing. You also log baby’s poops and pees.

This tells us a lot.

The log is for the first week of life, but there are many apps out there that you can continue to use beyond that.

When things are going well, your baby will breastfeed a minimum of eight to 12 times in a 24-hour period. That’s the minimum.

You can watch your baby’s sucking motions, paying careful attention to swallowing action and cheek movement.

Sometimes, you can actually hear your baby swallowing. That’s a good thing.

You’ll also notice a rhythm when your baby nurses. The suck-to-swallow ratio can change depending on what part of the feed they’re at. This also changes after the colostrum transitions to milk.

Some other things to keep in mind:

  • Typically by Day 5, baby should be having about five wet diapers and four to five poopy diapers. The color of the poopy diapers should transition from black (meconium) to greenish, then to yellow and seedy looking. By Day 5 we are looking for the yellow poops.
  • Watch to see if your baby is more content after feeding. At the beginning of a feeding, your baby may often want to place his hands in the way or in the mouth. As he fills his little tummy, he relaxes and his hands go into a more relaxed position.
  • Pay attention to baby’s weight. A baby will often lose weight after birth, usually up to 10% of the birth weight. By about Day 5, however, baby typically starts to gain some weight. We are looking for baby to be back to birth weight by about Day 10-14.

Painful latch

It’s important your baby learns to latch correctly in the beginning. Your baby has never nursed before—food in the womb came via the pipeline, as I like to tell new parents, and it came all the time.

They didn’t have to work for it.

Now, they have to learn to suck, swallow and breathe to get food.

We are looking for a deep latch at breastfeeding. This means your baby will have a lot of the dark part (areola) in her mouth, not just the nipple.

When baby latches on initially, it may be uncomfortable. But it shouldn’t be painful.

If it’s painful, baby is not latched correctly. Baby’s lips should look flanged outward.

How to get help

This is an area I am passionate about.

Having worked with breastfeeding moms for my entire OB career of floor nursing and education—plus nursing all six of my children—I became an International Board Certified Lactation Consultant.

People like me who work with breastfeeding moms want you to know one thing: There is help.

Give us a call. We always want to help.

If you encounter difficulty, don’t stop trying—your little one stands to reap so many benefits from breastmilk.

Source : Health Beat More   

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