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Cancer Drug
AstraZeneca Pharma on Tuesday said it has received approval from the national drug regulator to market a cancer treatment drug in the country. The company has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan for an additional indication in India, the drug firm said in a statement. With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours, who have received prior systemic therapy and have no satisfactory alternative treatment options, it added. This marks the first and only antibody drug conjugate in India with a tumour-agnostic indication, representing a significant advancement in precision oncology, the company said. "This milestone reflects our unwavering commitment to patient-centricity, scientific excellence, and equitable access to breakthrough therapies. By bringing Trastuzumab Deruxtecan to ..
Drug major Cipla on Friday said it has received approval from the US health regulator to market a generic cancer treatment drug. The company has received the final approval from the US Food and Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) submitted for paclitaxel protein-bound particles for injectable suspension (albumin-bound), 100 mg/vial, single-dose vial, Cipla said in a regulatory filing. Cipla's protein-bound paclitaxel is a generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane for injectable suspension 100 mg/vial. Protein-bound paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in the first half of the current fiscal year in the US, the Mumbai-based drugmaker said. Shares of the company were trading 2.73 per cent up at Rs 1,454.90 apiece on the BSE.
The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives? In a new study, researchers found that most cancer drugs granted accelerated approval do not demonstrate such benefits within five years. Five years after the initial accelerated approval, you should have a definitive answer, said Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania who was not involved in the research. Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not." The program was created in 1992 to speed access to HIV drugs. Today, 85% of accelerated approvals go to cancer drugs. It allows the FDA to grant early approval to drugs that show promising initial results for treating debilitating or fatal diseases. In exchange, drug companies are expected to do rigorous testing and produce
Lupin on Monday said it has received a tentative approval from the US health regulator to market Dasatinib tablets, used to treat certain types of cancer, in America. The company in partnership with Pharmascience Inc. has received approval from the US Food and Drug Administration (FDA) for Dasatinib tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, it said in a statement. The Mumbai-based drug maker's product is a generic version of Bristol-Myers Squibb Company's Sprycel tablets. As per IQVIA MAT data, Dasatinib tablets had an estimated annual sale of USD 1,569 million in the US. Shares of Lupin settled at Rs 662.50 apiece, up 1.49 per cent on the BSE.