Cabanib-20 (XL184) Drug International Pharma

Product Name: Cabozantinib

English Name: Cabozantinib

Specification: 20 mg × 90 capsules/box

Manufacturer: Drug International Pharma

Cabozantinib is a multi-targeted, broad-spectrum anticancer drug capable of inhibiting at least nine distinct targets, including MET, VEGFR1/2/3, ROS1, RET, AXL, NTRK, and KIT.

Currently, Cabozantinib has demonstrated significant therapeutic efficacy across a wide range of solid tumors, including kidney cancer, thyroid cancer, liver cancer, soft tissue sarcoma, non-small cell lung cancer, prostate cancer, breast cancer, ovarian cancer, and colorectal cancer. It is particularly effective in controlling bone metastases. Due to its broad efficacy against multiple cancer types, Cabozantinib is often referred to as the "universal remedy" among targeted therapies, possessing broad-spectrum anticancer capabilities.

Treatment of Renal Cell Carcinoma: The response rate of Cabozantinib is several times higher than that of Sutent (46% vs. 18%), and it significantly extends overall survival (30.3 months vs. 21.8 months). The side effect profiles of both drugs are quite similar, with adverse event rates of 67% and 68%, respectively. The primary side effects include diarrhea, fatigue, hypertension, and hand-foot syndrome. Currently, Cabozantinib has become a preferred first-line treatment option for advanced kidney cancer.

Treatment of Hepatocellular Carcinoma: In patients with advanced liver cancer treated with Cabozantinib, overall survival was significantly prolonged, and the risk of death was reduced by 37%. The objective response rate was approximately 5%. Currently, alongside drugs such as Regorafenib and PD-1 antibodies, Cabozantinib has established itself as one of the key therapeutic agents for advanced liver cancer.

Treatment of Lung Cancer: Among patients with non-small cell lung cancer, approximately 2% harbor RET gene rearrangements. These patients are eligible for treatment with Cabozantinib. In 2016, the prestigious medical journal *The Lancet Oncology* published clinical trial data regarding the use of Cabozantinib in lung cancer patients with RET rearrangements: among 26 patients, the response rate was 28%, and the disease control rate approached 100%. Furthermore, for lung cancer patients with wild-type EGFR whose first-line treatment has failed, the use of Cabozantinib in combination with Tarceva (Erlotinib) significantly extended survival compared to using either Cabozantinib or Tarceva alone. The median survival in the combination therapy group was 13.3 months, compared to 9.2 months in the Cabozantinib monotherapy group and 5.1 months in the Tarceva monotherapy group.

Treatment of Thyroid Cancer: For thyroid cancer patients harboring *RET* mutations, Cabozantinib significantly extended overall survival, increasing it from 18.9 months to 44.3 months—more than a twofold increase. In the overall patient population, overall survival also increased from 21.1 months to 26.6 months.

Cabozantinib targets numerous molecular pathways; some of these targets are involved in the formation of bone metastases. Consequently, the drug demonstrates excellent efficacy in controlling bone metastases associated with solid tumors and has been widely utilized in the treatment of bone metastases arising from renal cell carcinoma and prostate cancer.

Cabozantinib can enhance the efficacy of immunotherapies—such as PD-1 antibodies—by mechanisms that include eliminating "myeloid-derived suppressor cells" (MDSCs) and other immunosuppressive cells that surround the tumor and facilitate its growth. As a result, numerous studies have identified Cabozantinib as an "ideal partner" for PD-1 antibodies, utilizing it in combination therapies that have yielded favorable clinical outcomes.

Indications:

Cabozantinib has a broad range of indications, primarily including:

(1) Advanced renal cell carcinoma in patients who have previously received anti-angiogenic therapy;

(2) Medullary thyroid carcinoma that is not amenable to surgical resection;

(3) Hepatocellular carcinoma (liver cancer) in patients who have developed resistance to Nexavar (Sorafenib);

(4) Advanced prostate cancer in patients presenting with bone metastases.

Dosage and Administration:

(1) The recommended dosage is 140 mg daily (consisting of one 80 mg capsule and three 20 mg capsules);

(2) The medication must not be taken with food;

(3) Patients should refrain from eating for at least 2 hours—specifically, for at least 1 hour before taking the medication and for at least 1 hour after taking it;

(4) In the event of adverse reactions, dose reduction or temporary interruption of treatment may be considered. Adverse Reactions:

The most commonly reported adverse drug reactions (≥25%) associated with Cabozantinib are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), weight loss, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation.

Manufacturer Profile:

Drug International Ltd (DIL) is a long-established pharmaceutical company based in Bangladesh; it stands as one of the country's largest pharmaceutical enterprises and a prominent national industry leader. Founded in 1980 by Dr. M.M. Amjad Hussain, DIL emerged during an era when Bangladesh faced significant economic underdevelopment and poverty. Since its inception, the company—characterized by a low-profile, cost-effective operational style—has made immense contributions to the health and well-being of countless Bangladeshi citizens. Driven by this corporate ethos of benefiting both the nation and its people, DIL rose to become Bangladesh's third-largest manufacturer of pharmaceutical raw materials by 1997. Consistently ranked among Bangladesh's most renowned pharmaceutical firms, the company also serves as a key partner to Novartis—one of the world's top three pharmaceutical corporations. The DIL Group's diverse portfolio encompasses three large-scale pharmaceutical manufacturing plants, a biopharmaceuticals facility, a health supplements factory, an oncology research and development center, the Khwaja Yunus Ali Medical College, as well as tea estates, garment manufacturing units, ceramics production, printing facilities, and a software development firm. Operating in over 70 countries worldwide, the company offers a comprehensive product line ranging from medical devices to a wide variety of finished pharmaceutical products, currently comprising more than 500 distinct medications.