The first indication has just been corrected, and the FDA has accelerated the approval of Trodelvy's second indication-bladder cancer

Recently (April 13, 2021), Gilead announced that the FDA has accelerated its approval of a new indication for its targeted Trop-2-ADC drug Trodelvy (sacituzumab govitecan-hziy)-locally advanced or metastatic urothelial cancer.
The disease progressed after receiving platinum-based chemotherapy and immunotherapy.

Trodelvy Trodelvy is a drug that targets Trop-2-ADC.
It uses the humanized antibody hRS7 as a targeting carrier to couple with the active metabolite SN38 of irinotecan.

On April 23, 2020, Trodelvy received accelerated FDA approval for patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two treatments.
This is the first ADC drug specifically designed to treat relapsed or refractory mTNBC.
It is also the first ADC drug that targets Trop-2 approved by the FDA.

Based on the stunning clinical data of its Phase III ASCENT trial, one week ago (April 7, 2021), the FDA has upgraded Trodelvy’s accelerated approval to full approval for metastatic triple-negative patients who have received at least two or more treatments Treatment of patients with breast cancer (mTNBC).

The accelerated approval of the new indication is based on data from a phase II clinical trial called TROPHY.
In this clinical study, 27.
7% of patients with metastatic urothelial cancer treated with Trodelvy achieved remission and 5.
4% Complete remission, 22.
3% partial remission, median duration of remission was 7.
2 months.

The safety of Trodelvy in TROPHY is consistent with that observed in other tumors, with 10% of patients discontinuing treatment due to treatment-related adverse events.

When the FDA approved Trodelvy for the treatment of mTNBC, it put a black box warning on the label, indicating that severe neutropenia and diarrhea may occur after the drug is taken.

The broad-spectrum target Trop2 is a broad-spectrum target with a variety of potential indications.
It is highly expressed in a variety of tumors, such as pancreatic cancer, breast cancer, colon cancer, gastric cancer, oral squamous cell carcinoma, and ovarian cancer.

Trop2 can promote tumor cell proliferation, invasion, metastasis and spread, and its high expression is closely related to the shortened survival and poor prognosis of tumor patients.

The successful listing of Trodelvy brought this target into the public's field of vision, and now it has become the second most popular target in the ADC field.
There are currently Daiichi Sankyo, Hangzhou Duoxisheng/Junshi, Kelun, Genting Xinyao/Immunomedics, Biotech and many other pharmaceutical companies have layout.
Domestically, Genting Xinyao is a little faster.
It directly introduced Trodelvy from Immunomedics.
It has now advanced to the clinical phase II stage.
Biotech has been out of the market.
Other companies Trop-2-ADC are in The clinical progress of research products is basically on the same level.

In addition to the above-mentioned pharmaceutical companies, the TROP-2 layout research and development also includes the second-tier Sinopharm Group, Hausen Pharmaceuticals, and Luoqi Biological.
Prior to this, all three companies have published patents for their candidate products.

In addition to ADC drugs, Henlius also introduced TROP-2 monoclonal antibody from Chiom earlier this year.

The editor concludes that starting from 2019, global ADC has entered a period of rapid development.

As the first product to win the title of this target, Trodelvy's first-mover advantage is obvious.
American securities company Cowen once predicted that the peak sales of this drug is expected to reach 4 billion US dollars per year.

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