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Rachel V Thomas

Daraxonrasib: US FDA Approves Once-Daily Pill for Metastatic Pancreatic Cancer

The US Food and Drug Administration (<span>FDA</span>) has approved Rasonque (<span>daraxonrasib</span>), a once-daily pill, for adults with metastatic pancreatic adenocarcinoma, offering a new treatment option for patients with advanced <span>pancreatic cancer</span>.

Rasonque is a once-daily tablet that targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, which arises from cells lining the ducts of the pancreas.

The approval is for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.  

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” said Acting FDA Commissioner Kyle Diamantas, JD.

<h2>Pancreatic Cancer Remains Difficult To Treat</h2>

Also read: <a href="https://www.healthandme.com/health-wellness/former-us-senator-ben-sasse-opens-up-about-battle-with-terminal-stage-4-pancreatic-cancer-article-154042531" data-type="tilCustomLink">Former US Senator Ben Sasse Opens Up About Battle With Terminal Stage 4 Pancreatic Cancer</a>

Pancreatic cancer has long been one of the toughest challenges in oncology. The five-year survival rate is around 13%, while recurrence rates approach 80% after treatment.

Approximately 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed in the US each year are pancreatic adenocarcinoma, according to the National Cancer Institute.

Although pancreatic cancer represents roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths because of its typically late detection, aggressive disease course and historically limited treatment options.

However, daraxonrasib, developed by US-based late-stage clinical oncology company <span>Revolution Medicines</span>, has shown promise in improving survival among patients with <span>metastatic pancreatic cancer</span>.

Daraxonrasib is a once-daily oral pill that demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard intravenous chemotherapy.

The drug is described as a multi-selective inhibitor of RAS(ON) proteins and is the first approved drug in this new class of RAS inhibitors designed to target a broad spectrum of cancer-causing RAS mutations.

Daraxonrasib works by blocking KRAS signaling proteins that drive tumour growth. Pancreatic cancer is considered one of the most RAS-driven cancers, with more than 90% of patients carrying tumo\rs driven by RAS protein mutations.

Read More: <a href="https://www.healthandme.com/health-news/new-pancreatic-cancer-drug-daxaronrasib-may-benefit-patients-with-lung-and-ovarian-tumors-too-article-154439036" data-type="tilCustomLink">New Pancreatic Cancer Drug Daxaronrasib May Benefit Patients With Lung And Ovarian Tumors Too</a>

The FDA approval is specifically for adults with metastatic pancreatic adenocarcinoma in two situations:

<ul><li>Patients who have received at least one prior systemic therapy.</li><li>Patients who are not candidates for multiagent systemic therapy. </li></ul>

In the Phase 3 clinical trial, including 500 adults, daraxonrasib led to a median overall survival of 13.2 months, compared 

Daraxonrasib also significantly improved progression-free survival compared with chemotherapy. Similar RAS-targeting drugs are now being developed by other companies for pancreatic, lung and colon cancers.

According to the company, daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals. Prior studies with daraxonrasib have shown that rash is the most common side effect. Mouth sores, diarrhoea, nausea and vomiting have also been reported.

<h2>Pancreatic Cancer: Know The Warning Signs</h2>

Pancreatic cancer typically begins in the ducts of the organ and can rapidly spread to other parts of the body. Early-stage pancreatic tumours may not show up on imaging tests, making the disease difficult to diagnose until it has spread to other organs.

Prevention and early detection remain vital. Pancreatic cancer can often resemble common ailments, potentially delaying diagnosis.

<strong>Symptoms That Should Not Be Ignored</strong>

<ul><li>Abdominal or back pain </li><li>Unexplained weight loss</li><li>Jaundice</li><li>Changes in urine or stool</li><li>New-onset diabetes</li><li>Persistent fatigue.</li></ul>

Health Conditions A-Z

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daraxonrasib-us-fda-approves-once-daily-pill-for-metastatic-pancreatic-cancer

Pancreatic Cancer

Daraxonrasib

Metastatic Pancreatic Cancer

Revolution Medicines

RAS inhibitor

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The US Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a once-daily pill, for adults with metastatic pancreatic adenocarcinoma, offering a new treatment option for patients with advanced pancreatic cancer.Rasonque is a once-daily tablet that targets multiple forms of a protein called RAS, a key driver of tumor growth in most patients with pancreatic adenocarcinoma, which arises from cells lining the ducts of the pancreas.The approval is for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.  “Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” said Acting FDA Commissioner Kyle Diamantas, JD.Pancreatic Cancer Remains Difficult To TreatAlso read: Former US Senator Ben Sasse Opens Up About Battle With Terminal Stage 4 Pancreatic CancerPancreatic cancer has long been one of the toughest challenges in oncology. The five-year survival rate is around 13%, while recurrence rates approach 80% after treatment.Approximately 90% to 95% of the 67,000 new pancreatic cancer cases diagnosed in the US each year are pancreatic adenocarcinoma, according to the National Cancer Institute.Although pancreatic cancer represents roughly 3.2% of all cancer diagnoses, pancreatic adenocarcinoma accounts for a disproportionately high share of cancer deaths because of its typically late detection, aggressive disease course and historically limited treatment options.However, daraxonrasib, developed by US-based late-stage clinical oncology company Revolution Medicines, has shown promise in improving survival among patients with metastatic pancreatic cancer.What Is Daraxonrasib?Daraxonrasib is a once-daily oral pill that demonstrated statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) compared with standard intravenous chemotherapy.The drug is described as a multi-selective inhibitor of RAS(ON) proteins and is the first approved drug in this new class of RAS inhibitors designed to target a broad spectrum of cancer-causing RAS mutations.Daraxonrasib works by blocking KRAS signaling proteins that drive tumour growth. Pancreatic cancer is considered one of the most RAS-driven cancers, with more than 90% of patients carrying tumo\rs driven by RAS protein mutations.Who Can Take Daraxonrasib?Read More: New Pancreatic Cancer Drug Daxaronrasib May Benefit Patients With Lung And Ovarian Tumors TooThe FDA approval is specifically for adults with metastatic pancreatic adenocarcinoma in two situations:Patients who have received at least one prior systemic therapy.Patients who are not candidates for multiagent systemic therapy. Daraxonrasib Clinical TrialIn the Phase 3 clinical trial, including 500 adults, daraxonrasib led to a median overall survival of 13.2 months, compared with 6.7 months with chemotherapy. Daraxonrasib also significantly improved progression-free survival compared with chemotherapy. Similar RAS-targeting drugs are now being developed by other companies for pancreatic, lung and colon cancers.What Are The Side Effects?According to the company, daraxonrasib was generally well tolerated, with a manageable safety profile and no new safety signals. Prior studies with daraxonrasib have shown that rash is the most common side effect. Mouth sores, diarrhoea, nausea and vomiting have also been reported.Pancreatic Cancer: Know The Warning SignsPancreatic cancer typically begins in the ducts of the organ and can rapidly spread to other parts of the body. Early-stage pancreatic tumours may not show up on imaging tests, making the disease difficult to diagnose until it has spread to other organs.Prevention and early detection remain vital. Pancreatic cancer can often resemble common ailments, potentially delaying diagnosis.Symptoms That Should Not Be IgnoredAbdominal or back pain Unexplained weight lossJaundiceChanges in urine or stoolNew-onset diabetesPersistent fatigue.

daraxonrasib: us fda approves once-daily pill for metastatic pancreatic cancer

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Daraxonrasib: US FDA Approves Once-Daily Pill for Metastatic Pancreatic Cancer

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