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9 September, 2019 00:00 00 AM

FDA approves Rozlytrek (entrectinib) for metastatic non-small cell lung cancer and NTRK Gene fusion-positive solid tumors

Genentech
FDA approves Rozlytrek (entrectinib) for metastatic non-small cell lung cancer and NTRK Gene fusion-positive solid tumors

Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.

These approvals are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/II STARTRK-NG study. In the integrated analysis, Rozlytrek was studied in several solid tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

In ROS1-positive, metastatic NSCLC, Rozlytrek shrank tumors in 78% of people with the disease (overall response rate [ORR]; N=51) and the duration of response (DoR) ranged from 1.8 to 36.8+ months (N=40 out of 51). Rozlytrek also shrank tumors in more than half of people with NTRK gene fusion-positive, locally advanced or metastatic solid tumors (ORR=57%; N=54), and objective responses were observed across 10 tumor types (DoR ranged from 2.8 to 26.0+ months; N=31 out of 54). Objective responses to Rozlytrek were seen in people with central nervous system (CNS) metastases at baseline.

The most common adverse reactions (≥20 percent) with Rozlytrek were fatigue, constipation, altered sense of taste (dysgeusia), swelling (edema), dizziness, diarrhea, nausea, nervous system disorders (dysesthesia), shortness of breath (dyspnea), muscle pain (myalgia), cognitive impairment, increased weight, cough, vomiting, fever (pyrexia), joint pain (arthralgia) and vision disorders.

Indication

Rozlytrek is a prescription medicine used to treat:

Adults with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by an abnormal ROS1 gene

Adults and children 12 years and older with solid tumors (cancer) that:

are caused by certain abnormal NTRK genes and

have spread or if surgery to remove their cancer is likely to cause severe complications, and

there is no satisfactory alternative treatment option or the cancer grew or spread on other treatment

It is not known if Rozlytrek is safe and effective for use in children less than 12 years of age.

Important Safety Information

Rozlytrek may cause serious side effects, including:

Congestive heart failure. Rozlytrek may cause congestive heart failure or make the congestive heart failure that a patient already has worse. Patients should tell their healthcare provider right away if they have any of the following signs and symptoms of congestive heart failure:

persistent coughing or wheezing

trouble breathing when lying down

sudden weight gain

increasing shortness of breath

tiredness, weakness, or fatigue

swelling in ankles, feet, or legs

Central nervous system (CNS) effects. Rozlytrek may cause dizziness, changes in mood, or may affect how a patient thinks and cause confusion, hallucinations, and problems with concentration, attention, memory, and sleep. Patients should tell their healthcare provider right away if they have any of these symptoms.

Bone fractures. Rozlytrek may increase the risk of bone fractures. Bone fractures may happen with or without a fall or other injury. Patients should tell their healthcare provider if they have pain, changes in movement, or bone abnormalities.

Liver problems (hepatotoxicity). A healthcare provider will do blood tests to check a patient’s liver function during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they develop symptoms of liver problems including: loss of appetite, nausea or vomiting, or pain on the upper right side of the stomach area. A healthcare provider may temporarily stop treatment, decrease the dose, or permanently stop Rozlytrek if a patient develops liver problems with Rozlytrek.

Increased uric acid level in the blood (hyperuricemia). Rozlytrek may cause an excess of uric acid in the blood. A healthcare provider may do tests before and during a patient’s treatment with Rozlytrek to check the uric acid level in the blood. A healthcare provider may prescribe medications if a patient has high blood uric acid levels.

Changes in the electrical activity of the heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. A healthcare provider will do tests before and during treatment with Rozlytrek to check the electrical activity of the heart and body salts (electrolytes). Patients should tell their healthcare provider right away if they feel faint, lightheaded, dizzy, or feel their heart beating irregularly or fast while taking Rozlytrek. These may be symptoms related to QT prolongation.

Vision problems. Rozlytrek may cause vision problems. Healthcare providers may stop Rozlytrek and refer to an eye specialist if a patient develops severe vision problems during treatment with Rozlytrek. Patients should tell their healthcare provider right away if they have any loss of vision or any change in vision, including:

double vision

blurry vision

new or increased floaters

seeing flashes of light

light hurting the eyes

Before taking Rozlytrek, patients should tell their healthcare provider about all their medical conditions, including if they:

have liver or kidney problems.

have any heart problems, including a condition called long QT syndrome.

have nervous system (neurological) problems.

have or have had eye or vision problems.

are pregnant or plan to become pregnant. Rozlytrek can harm an unborn baby. Patients should tell their healthcare provider right away if they become pregnant during treatment with Rozlytrek or think they may be pregnant.

If patients are able to become pregnant, their healthcare provider will do a pregnancy test before they start treatment with Rozlytrek.

Females who are able to become pregnant should use effective birth control during treatment with Rozlytrek and for at least 5 weeks after the final dose.

Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rozlytrek and for 3 months after the final dose.

are breastfeeding or plan to breastfeed. It is not known if Rozlytrek passes into breast milk. Do not breastfeed during treatment with Rozlytrek and for 7 days after the final dose of Rozlytrek. Patients should talk to their healthcare provider about the best way to feed their baby during this time.

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, or herbal supplements.

Certain other medicines may affect how Rozlytrek works causing side effects. Patients should know the medicines they take. Patients should keep a list of them to show to their healthcare provider and pharmacist when they get a new medicine.

The most common side effects of Rozlytrek include:

tiredness

constipation

change in taste

swelling

dizziness

diarrhea

nausea

abnormal touch sensation

shortness of breath

muscle pain

confusion, mental status changes, memory problems, and hallucinations

cough

vomiting

fever

joint pain

vision changes

These are not all the possible side effects of Rozlytrek.

Patients should call their doctor for medical advice about side effects.

Courtesy: drugs.com

 

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Editor : M. Shamsur Rahman

Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

Editor : M. Shamsur Rahman
Published by the Editor on behalf of Independent Publications Limited at Media Printers, 446/H, Tejgaon I/A, Dhaka-1215.
Editorial, News & Commercial Offices : Beximco Media Complex, 149-150 Tejgaon I/A, Dhaka-1208, Bangladesh. GPO Box No. 934, Dhaka-1000.

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