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'accelerated approval based'

Items tagged with 'accelerated approval based'

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Anti Cancer

COMPOSITION: Each film-coated tablet contains Tepotinib hydrochloride hydrate 250mg equivalent to Tepotinib…………………………….225mg. INDICATION: LuciTepo is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal epithelial transition (MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. DOSAGE AND USE: • Select patients for treatment with LuciTepo on the presence of METex14 skipping. • Recommended dosage: 450mg orally once daily with food until disease progression or unacceptable toxicity. STORAGE: In a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each LuciRepo capsule contains: Repotrectinib ………………………….…… 40mg INDICATION: LuciRepo is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). DOSAGE AND USE: • Select patients for the treatment of locally advanced or metastatic NSCLC based on the presence of ROS1 rearrangement(s) in tumor specimens. • Recommended Dosage: 160 mg orally once daily for 14 days, then increase to 160 mg twice daily, with or without food. Capsules should be swallowed whole & not chewed or crushed. STORAGE: In a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each LuciEntre capsule contains: Entrectinib ……. 100mg INDICATION: LuciEntre is a kinase inhibitor indicated for the treatment of: • Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. • Adult and pediatric patients 12 years of age and older with solid tumors that: ▪have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion as detected by an FDA-approved test 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. DOSAGE AND USE: • Recommended Dosage for ROS1-Positive Non-Small Cell Lung Cancer: 600 mg orally once daily. • Recommended Dosage for NTRK Gene Fusion-Positive Solid Tumors: ▪Adults: 600mg orally once daily. ▪Pediatric Patients 12 Years and Older: Recommended dosage is based on body surface area (BSA) as shown below □ BSA greater than 1.50 m2: 600 mg once daily. □ BSA 1.11 to 1.50 m2: 500 mg once daily. □ BSA 0.91 to 1.10 m2: 400 mg once daily. Capsules should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each LUCIVIGA tablet contains Vigabatrin…500 mg. INDICATION: LUCIVIGA is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments. DOSAGE AND USE: Refractory Complex Partial Seizures • Adults (17 years of age and older): Initiate at 1000 mg/day (500 mg twice recommended dose of 3000 mg/day (1500 mg twice daily) • Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses. As shown in following: Body Weight Starting Dose Total Daily Maintenance Dose Total Daily 10kg~15kg 350mg 1050mg Greater than 15kg to 20kg 450mg 1300mg Greater than 20kg to 25kg 500mg 1500mg Greater than 25kg to 60kg 500mg 2000mg Pediatric patients weighing more than 60 kg should be dosed according to adult recommendations. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each film-coated tablet contains tucatinib….150 mg INDICATION: LuciTuca is a kinase inhibitor indicated: • in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. • in combination with trastuzumab for the treatment of adult patients with RAS wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-,oxaliplatin-,and irinotecan-based chemotherapy. DOSAGE AND USE: • In patients with unresectable or metastatic colorectal cancer, confirm the presence of HER2 protein overexpression and RAS wild-type in tumor specimens prior to the initiation of LuciTuca. • Recommended dosage: 300 mg taken orally twice daily with or without food. • For patients with severe hepatic impairment, the recommended dosage is 200 mg orally twice daily. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 45mg. INDICATION: ndication: LuciPona is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL. Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. DOSAGE AND USE: • Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1. • Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily. • Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily. LuciPona may be taken with or without food. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each tablet contains Ponatinib HCl 16.03mg equivalent to Ponatinib…………………………………………………….. 15mg. INDICATION: ndication: LuciPona is a kinase inhibitor indicated for the treatment of adult patients with: • Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. • Accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) for whom no other kinase inhibitors are indicated. • T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ALL. Limitations of Use: LuciPona is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. DOSAGE AND USE: • Recommended Dosage in CP-CML: Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR-ABL1. • Recommended Dosage in AP-CML, BP-CML, and Ph+ALL: Starting dose is 45 mg orally once daily. • Hepatic Impairment: Reduce the starting dose to 30 mg orally once daily. LuciPona may be taken with or without food. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each LuciLenva capsule contains: 12.25mg Lenvatinib mesylate equivalent to Lenvatinib.………10mg INDICATION: LuciLenva is a kinase inhibitor that is indicated: 1. For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). 2. In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC). 3. For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). DOSAGE AND USE: 1. DTC: The recommended dosage is 24 mg orally once daily. 2. RCC: The recommended dosage is 18 mg orally with everolimus 5 mg orally once daily. 3. HCC: The recommended dosage is based on actual body weight: · 12 mg orally once daily for patients greater than or equal to 60 kg · 8 mg orally once daily for patients less than 60 kg. Capsules should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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Anti Cancer

COMPOSITION: Each LuciLenva capsule contains: 12.25mg Lenvatinib mesylate equivalent to Lenvatinib.………4mg INDICATION: LuciLenva is a kinase inhibitor that is indicated: 1. For the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (DTC). 2. In combination with everolimus, for the treatment of patients with advanced renal cell carcinoma (RCC). 3. For the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). DOSAGE AND USE: 1. DTC: The recommended dosage is 24 mg orally once daily. 2. RCC: The recommended dosage is 18 mg orally with everolimus 5 mg orally once daily. 3. HCC: The recommended dosage is based on actual body weight: · 12 mg orally once daily for patients greater than or equal to 60 kg · 8 mg orally once daily for patients less than 60 kg. Capsules should be swallowed whole & not chewed or crushed. STORAGE: in a dry place and store at 20°C to 25°C. MANUFACTURED AND MARKETED BY: LUCIUS PHARMACEUTICALS(LAO) CO., LTD No.26, Thongmang village, Xaythany district, Vientiane Capital, Laos

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