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Another FDA Treatment Approval Underscores Promise of Precision Medicine – Pancreatic Cancer Action Network


doctor with tablet talking to patient

The FDA recently granted accelerated approval for a drug targeting a specific genetic alteration that can drive cancer growth – called RET fusion – additional evidence of precision medicine’s potential to bring effective treatments to patients with pancreatic cancer based on their tumor’s biology. RET stands for rearranged during transfection, and the RET gene can mistakenly join, or fuse, with other genes to produce a protein that promotes cancer formation.

The drug, called Retevmo® (selpercatinib 40 mg & 80 mg capsules), is a RET inhibitor that has been approved to treat certain types of thyroid or lung cancer. Now it’s available to patients with RET fusion-positive cancer, regardless of the location of their tumor. Patients who have locally advanced or metastatic cancer that has progressed despite prior systemic treatment or who have no satisfactory alternative treatment options can receive the drug.

The targeted therapy was shown to be effective across a variety of RET fusion-positive solid tumor types, including pancreas, colon and others, underscoring the importance of biomarker testing to identify the most effective therapy based on the biology of a patient’s tumor. Patients with pancreatic cancer who receive treatment based on their biology, known as precision medicine, can live longer.

RET fusions occur in 7-8% of patients with gastrointestinal (GI) cancers, including pancreatic cancer.

In a press release from pharmaceutical company Eli Lilly announcing the approval, PanCAN President and CEO Julie Fleshman, JD, MBA, commented on the importance of the news.

She said that Retevmo’s expanded label is an “opportunity to bring more targeted treatment options to a broader set of difficult-to-treat solid tumors, such as pancreatic cancer. This news further highlights the importance of broad biomarker testing, which may open the door to new therapy options for more patients.”

In their announcement, Eli Lilly reports that of the 41 patients included in the trial, 39% had a partial response to the treatment, which means that their tumor shrank, and 4.9% had a complete response to the treatment and there was no evidence of cancer. The median duration of response was 24.5 months. Eleven patients in the data set had pancreatic cancer. Six of them responded to the treatment.

Additional data from the clinical trial that led to the approval of Retevmo were published earlier this month in the prestigious journal Lancet Oncology.

Retevmo was approved using the FDA Accelerated Approval process – which is meant to fast-track drugs that are reasonably likely to show clinical benefit, such as shrinking a tumor. This means that the drug can be prescribed, but researchers must still continue to study the drug to make sure it is safe and effective in order to remain approved.

This announcement from Eli Lilly comes just a few months after drug maker Novartis received accelerated FDA approval for a treatment targeting a specific mutation that drives cancer growth in more than 20 tumor types, called the BRAF V600E mutation.

The approvals reinforce the importance of biomarker testing to identify genetic mutations or alterations that could be targeted by drugs.

PanCAN strongly recommends all pancreatic cancer patients get biomarker testing of their tumor tissue to determine the best treatment options. The tests can be available through their treating institution or PanCAN’s Know Your Tumor® precision medicine service.



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