Is alpelisib fda approved?

If you’re anything like me, you have a hard time keeping track of all the different drugs out there on the market. I mean, there are so many! And they all seem to have these crazy long names you can’t even begin to pronounce.

That’s why I’m here today: to talk about alpelisib and answer the burning question on everyone’s minds – is it FDA approved?

The basics of alpelisib

First things first – let’s break down what exactly this fancy drug is. Alpelisib (also known as BYL719) is a medication used in the treatment of breast cancer.

More specifically, alpelisib targets patients whose tumor cells feature PIK3CA mutations. Now, if that sounds like gibberish don’t worry – we’ll go over that in just a minute.

The most important thing to know right now is that alpelisib works by inhibiting an enzyme called “PI3 kinase” which plays an important role in cancer cell growth and proliferation. Pretty cool stuff!

What does “FDA approval” actually mean?

Now let’s get down to brass tacks: what does it actually mean for a drug to be “FDA approved”?

Basically, when a new drug hits the market (or intends to), it undergoes rigorous testing across multiple phases of clinical trials. These tests evaluate both safety and efficacy; that is, whether or not taking the medication produces positive health outcomes without introducing any major risks or side effects.

Once those tests have been successfully completed and analyzed (which can take years!), companies submit their findings along with an application package seeking FDA approval for their product. If everything checks out and looks good from an ethical standpoint as well (cough cough Theranos), then congratulations! Your drug gets officially approved by one of the most esteemed regulatory agencies in the world.

So, is alpelisib FDA approved or nah?

Alright, drumroll please…it’s time to answer the question we’ve all been waiting for! Is alpelisib a big enough deal to have earned its coveted “FDA approved” badge?

Yes. Yes it is!

In May of 2019, the U.S. Food and Drug Administration granted accelerated approval of alpelisib in combination with fulvestrant for treating advanced or metastatic breast cancer featuring PIK3CA mutations.

This was HUGE news at the time because up until then there weren’t really any targeted therapies available for this specific subgroup of breast cancer patients.

Of course though, as they say: better late than never!

A closer look at those darned PIK3CA mutations

So earlier I mentioned that alpelisib works by specifically targeting patients whose tumor cells showcase these mysterious sounding PIK3CA mutations. But what are those exactly? And why do they matter so much when it comes to designing treatments?

First off, let’s break down what PIK3CA even stands for (I bet you’re on pins and needles!). It actually refers to one specific gene within our DNA that provides instructions for creating an enzyme involved in cell signaling pathways called phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (a.k.a. PI(3) kinase).

However you choose to pronounce that long string of syllables is entirely your business – I won’t judge!

Anyways, certain types of cancers often exhibit hotspots within their genome where significant genetic alterations occur far more frequently than elsewhere throughout the same sequence. One such hotspot can be found within this very gene – go figure! The result typically manifests as some sort of mutation within the PIK3CA sequence.

This mutation makes that cellular signaling pathway particularly active – essentially telling cells to divide and proliferate at a much faster rate than they would under normal circumstances (aka runaway cancer growth). Alpelisib then comes in and halts this misleading pathway, stopping tumors from spreading so rampantly.

How is alpelisib taken?

So now we’ve covered what alpelisib is actually intended for, but how does one go about taking it? Are there any special considerations to keep in mind before diving into treatment headfirst?

Well firstly, it’s important to note that alpelisib should not be used during pregnancy or breastfeeding – no surprise there since most medications tend to carry those warnings along with them.

Otherwise though, dosage can vary depending on individual patient factors like weight and height. A typical course of treatment involves taking four pills of 300mg each daily around the same time of day. It’s also usually recommended that patients consume their dose with food as well!

What are some common side effects?

Of course when starting any new medication it’s natural to wonder: what kind of potential side effects should I anticipate? Will the cure be worse than the disease itself?!

Luckily for anyone considering whether or not they might benefit from using alpelisib, research has shown its honest-to-goodness benefits markedly outweigh its downsides.

That being said, adverse reactions still have been reported amongst study participants undergoing clinical trials over time. Some common ones include:

  • Hyperglycemia (high blood sugar)
  • Diarrhea
  • Nausea/vomiting
  • Loss of appetite
  • Fatigue/weakness

While none of these sound particularly pleasant (!), many experts affirm that these symptoms aren’t typically too severe and will likely improve as your body becomes accustomed to regular use!

That being said, if you start experiencing more worrisome issues like difficulty breathing or swelling of your face, lips, tongue or throat (also known as anaphylaxis), you should contact a medical professional immediately!

Final thoughts on alpelisib and its FDA approval status

So there we have it! After digging through all that scientific jargon and decoding what PIK3CA even stands for, we can say with certainty: alpelisib is in fact FDA approved.

While it might not be the most well-known drug out there among the masses (personally I still prefer aspirin for my regular headaches!), to patients struggling with breast cancer featuring these particular genetic markers alpelisib has proven itself a worthy ally. So if you or someone you know finds themselves facing this issue down the line somewhere – at least one potential path forward now exists!

I don’t know about you, but something about hearing names like “PIK3CA mutations” just makes me want to binge-watch some sci-fi films instead…but regardless of how intimidating medication labels may seem initially, chances are good that drugs like alpelisib will make huge strides towards treating serious conditions other remedies could never manage before!

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