ABSTRAL® is the novel, rapidly-disintegrating, sublingual formulation of fentanyl, a well-established opioid used for the management of episodes of breakthrough pain experienced by cancer patients who are already receiving opioid analgesics for chronic pain.
HALAVEN® (eribulin mesylate) Injection is a chemotherapy that offers an opportunity to live longer for women whose metastatic breast cancer (mBC) has progressed after at least 2 types of mBC therapy. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer. Halaven is developed from a natural substance found in a sea sponge, and is the only medicine discovered in its class of chemotherapy.
LENVIMA® is indicated for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).
PECFENT® is a nasally administrated spray which contains PecSys®. PecFent® is designed to optimise the absorption of fentanyl, matching drug absorption and clinical effect to the profile of a break through cancer pain episode experienced by cancer patients who are already receiving opioid analgesics for chronic pain.
SANCUSO® (Granisetron Transdermal System) is indicated for the prevention of nausea and vomiting in chemotherapy induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy regimens of up to 5 consecutive days duration. It is the first and only treatment for nausea and vomiting that does not require pills or an injection. It is a transdermal patch placed on the outside part of the upper arm that provides continuous control of nausea and vomiting through transdermal delivery.
ONCOTYPE DX® personalizes treatment options and improves outcomes. The Oncotype DX breast cancer test examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The test is supported by multiple rigorous clinical validation studies confirming the test’s ability to predict the likelihood of chemotherapy benefit as well as the chance of cancer recurrence in early-stage breast cancer. The test is intended for use in all newly diagnosed patients with early-stage (stage I, II or IIIa), breast cancer who have node-negative or node-positive (1-3), estrogen receptor-positive (ER+), HER2-negative disease. Oncotype DX testing helps patients and their physicians to optimize their cancer care and outcomes, enabling many patients to avoid unnecessary procedures and therapies.
Guardant Health AMEA is a joint venture between SoftBank and Guardant Health, a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. The Guardant Health oncology platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 7,000 oncologists, over 60 biopharmaceutical companies and all 28 National Comprehensive Cancer Network Centers in the United States. Visit our website: https://www.guardanthealthamea.com.
*for full prescribing information please refer to your locally approved label*
Sublingual tablet with fast onset of action for the treatment of breakthrough pain in cancer patients.
Name Abstral® Description Abstral™ provides fast and effective treatment of breakthrough pain in cancer patients. Abstral™ combines quick-dissolving sublingual tablet technology and the analgesic, fentanyl. Active Substance Fentanyl Indication Breakthrough cancer pain. Strengths 100, 200, 400 μg Regulatory Status
EMA approved June 2008; FDA approved January 2011.
Inserts Code #783939. Revision Date: March 2010.
Currently registered in Bahrain, Kuwait, Qatar, Oman, UAE, Lebanon and Sudan.
Under registration in KSA, Iraq, Egypt, Algeria, Morocco and Tunisia
Business Partner Kyowa Hakko Kirin Co. Ltd
HALAVEN® (eribulin mesylate) Injection - for intravenous administration only.
Name Halaven® (eribulin mesylate) Injection Description Halaven® is a microtubule inhibitor Indication Halaven® is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. StrengthsIntravenous administration. Eribulin mesylate injection, 1 mg per 2 mL (0.5 mg per mL).Administer 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle:
The recommended dose of Halaven® in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Halaven® in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.The recommended dose of Halaven® in patients with moderate renal impairment (creatinine clearance of 30-50 mL/min) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.Patients with severe Hepatic impairment (Child pugh C) and severe Renal impairment (CrCl ≤ 30 ml/min) were not studied.
- Reduce dose in patients with hepatic impairment and moderate renal impairment.
- Do not mix with other drugs or administer with dextrose-containing solutions.
- Premedication with steroids and/or antihistamines to prevent hypersensitivity reactions was not necessary in the ERIBULIN trials, and no special tubing was required for its administration.
Regulatory StatusEMA approved in March 2011; FDA approved in November 2010;Registered in KSA, Kuwait, UAE, Bahrain, Jordan and MoroccoUnder registration in Bahrain, Oman, Qatar, Algeria, Egypt and Sudan Business Partner EISAI
LENVIMA® (lenvatinib) capsules, for oral use
Name LENVIMA (lenvatinib) capsules Description LENVIMA is a kinase inhibitor Indication
Indicated for the treatment of:
- Differentiated Thyroid Cancer (DTC): single agent for patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC.
- Renal Cell Cancer (RCC): in combination with everolimus, for patients with advanced RCC following one prior anti-angiogenic therapy.
4 mg and 10 mg Capsules
- Differentiated Thyroid Cancer
- 24 mg orally, once daily
- Renal Cell Cancer
- 18 mg LENVIMA + 5 mg everolimus, orally, once daily
- Differentiated Thyroid Cancer
In patients with severe renal or hepatic impairment, the dose is 14 mg once daily in DTC and 10 mg once daily in RCC.
EMA approved in June 2015; FDA approved in February 2015
Registered in Kuwait
Under registration in GCC
Business Partner EISAI
PecFent Nasal Spray
Name PecFent nasal spray Description
Each ml of solution contains 1,000 micrograms fentanyl (as citrate)
1 spray (100 microlitres) contains 100 micrograms fentanyl (as citrate)
Each bottle contains 1.55 ml (1,550 micrograms fentanyl).
Indication PecFent is indicated for the management of breakthrough pain (BTP) in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Strengths
PectFent is available in two strengths: 100 micrograms/spray and 400 micrograms/spray
- The initial dose of PecFent to treat episodes of BTP is always 100 micrograms (one spray), even in patients switching from other fentanyl containing products for their BTP.
- Patients must wait at least 4 hours before treating another episode of BTP with PecFent.
Method of titration
- Patients should be prescribed an initial titration supply of one bottle (8 sprays) of PecFent 100 micrograms/spray.
- Patients whose initial dose is 100 micrograms and who need to titrate to a higher dose due to a lack of effect can be instructed to use two 100 microgram sprays (one in each nostril) for their next BTP episode. If this dose is not successful, the patient may be prescribed a bottle of PecFent 400 micrograms/spray and instructed to change to one 400 microgram spray for their next episode of pain. If this dose is not successful, the patient may be instructed to increase to two 400 microgram sprays (one in each nostril).
- From treatment initiation, patients should be closely followed and the dose titrated until an effective dose is reached and confirmed for two consecutively treated episodes of BTP.
EMA approved in June 2010; FDA approved in June 2011
Under registration in the MEA region
Business Partner Kyowa Hakko Kirin Co. Ltd
Sancuso® is a skin patch that slowly releases the medicine contained in the adhesive (glue), through clean and intact skin areas into the bloodstream while wearing the patch.
Name Sancuso® Description Sancuso® (Granisetron Transdermal System) is the first and only FDA-approved patch for the prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Active substance Granisetron Indication A serotonin subtype 3 (5-HT3) receptor antagonist indicated for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy for up to 5 consecutive days. Strengths 34.3mg (3.1mg/24 hours) Regulatory Status
Approved by United States Food and Drug Administration (FDA) in September 2008., Inserts Code #3001566., Revision date 08/08.
Registered in KSA, Bahrain, Kuwait, Oman, Qatar, UAE, Lebanon, Iran and Tunisia
Under registration in Egypt, Algeria and Morocco.
Business Partner Kyowa Hakko Kirin Co. Ltd.
Oncotype DX®, developed by Genomic Health®, is a diagnostic test that quantifies the likelihood of disease recurrence in women with early-stage hormone estrogen receptor (ER) positive only breast cancer (prognostic significance) and assesses the likely benefit from certain types of chemotherapy (predictive significance).
Name Oncotype DX ® Description Oncotype DX® is a diagnostic assay that quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, early stage breast cancer. In addition to predicting distant disease recurrence, Oncotype DX® also assesses the benefit from certain types of chemotherapy. The assay-performed using formalin-fixed, paraffin-embedded tumor tissue-analyses the expression of a panel of 21 genes and the results are provided as a Recurrence Score™ (0-100). The gene panel was selected and the Recurrence Score calculation was derived through extensive laboratory testing and multiple independent clinical development studies. Regulatory Status
CLIA- Certified (Clinical Laboratory Improvement Amendments of 1988)
CAP-accredited reference laboratory
Business Partner Genomic Health, Inc.
Guardant360® assay is a liquid biopsy that provides fast, accurate and comprehensive genomic results from a simple blood draw. Test results are available in approximately seven days upon receipt in the US laboratory.
The test is done using circulating tumor DNA (ctDNA), which is produced when tumors shed small pieces or their genetic material into the bloodstream.
Guardant360® assay examines a panel of 74 genes (specifications) to identify any alterations in the tumor DNA.
Since its launch in 2014, Guardant360® assay has been ordered by more than 6,000 oncologists over 100,000 times for patients with advanced cancer to help select treatment.
Use and indication
- Advanced stage – solid tumor -cancer patient with a solid tumor, whose tissue biopsy is insufficient for genetic testing.
- Advanced stage cancer patient who wants to identify targeted therapy options while avoiding an invasive repeated tissue biopsy.
To know more about Guardant360® assay please visit the https://www.guardanthealthamea.com or click on this link