Johnson and Johnson's new anti-tumor drug, Yondelis, was approved at the end of six years.

Drug development is a long-term process that takes a considerable amount of time from preclinical to clinical studies. However, in the face of stringent approval by the relevant pharmaceutical regulatory authorities, the cycle of drug development will become longer or even far away. Faced with this situation, many pharmaceutical companies have to choose to grit their teeth to stick to the approval marathon.
Johnson and Johnson, inc. recently announced that its anti-cancer drug Yondelis has been approved by the U.S. FDA for the treatment of soft tissue sarcoma. This marks the end of Yondelis's three-year,six-year approval marathon. In the future, Yondelis will be approved for treatment for patients with fatty sarcoma and smooth muscle tumors that cannot be surgically removed and treated with chemotherapy, the FDA said.
approval is based on the latest clinical Phase III findings submitted by Johnson and Johnson. In the study of 518 patients, Yondelis was able to significantly prolong the patient's survival compared to the traditional chemotherapy drug dacarbazine.
For Johnson and Johnson, Yondelis's approval is undoubtedly the end of a painful journey.
2001, Johnson and Johnson obtained the drug from Zeltia, a Spanish pharmaceutical company, and began research on Yondelis's treatment of ovarian cancer. In 2009, the FDA rejected a listing application for Yondelis and Doxil combination therapy because of excessive safety concerns and not significant efficacy. Two years later, for the same reason, Johnson and Johnson was forced to suspend the project and turn it to malignant sarcoma.
previously, with the efforts of Zeltia and other partners, Yondelis has been successfully listed in many countries and regions around the world. Six years later, Yondelis's approval in the U.S. market is undoubtedly an important addition to the drug market. After six years of marathoning, Johnson and Johnson, which has exclusive sales rights in the Yondelis U.S. market, may also breathe a sigh of relief.
Johnson and Johnson says soft tissue sarcoma is a rare malignant tumor that kills about 5,000 people each year. The two indications approved by Yondelis this time are the higher-malignant types of the tumor.
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