Immunomedics, Inc. IMMU announced that it has received the FDA approval for Trodelvy (sacituzumab govitecan-hziy), an antibody-drug conjugate (ADC), for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who received at least two prior therapies for metastatic disease. This marks the first FDA nod for any of this company’s pipeline candidates.
Continued approval may be contingent on the verification of clinical benefit in a confirmatory phase III ASCENT study, which was halted by the compelling evidence of efficacy, earlier this month. The decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) following its recent routine review of the ASCENT study.
In December 2019, the FDA accepted the biologics license application (BLA) for Trodelvy to address the given patient population. During the same month, the BLA application was refiled for the same.
We note that this approval came much before the scheduled Prescription Drug User Fee Act (PDUFA) action date of Jun 2, 2020. The BLA for Trodelvy was also granted a Breakthrough Therapy designation and a priority review under the accelerated approval program of the FDA, based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm phase II study.
Following the nod, Trodelvy became the first ADC to receive an FDA approval, specifically for the treatment of relapsed or refractory mTNBC, an aggressive type of breast cancer.
Shares of Immunomedics were up 29.6% in pre-market trading on Thursday following the above-mentioned news. In fact, the stock has increased 3.8% so far this year compared with the industry’s rise of 0.4%.
However, the prescribing information on Trodelvy comes with a black box warning.
We remind investors that in January 2019, Immunomedics received a complete response letter (CRL) from the FDA in relation to the BLA for Trodelvy. However, the CRL did not require conducting any new study. The company subsequently met the FDA officials to review the agency’s findings and discuss its BLA resubmission. In the CRL, the issues concerning the approval exclusively focused on chemistry, manufacturing and control matters.
Meanwhile, Trodelvy is being evaluated in several label expansion studies including earlier-line settings for breast cancer and other cancer indications.
We note that the nod for Trodelvy should provide a significant boost to Immunomedics in the days ahead as to date, the company had no approved products in its portfolio. The drug will be the first product to generate revenues for the company.
However, competition remains stiff in the breast cancer space from bigwigs like Roche RHHBY, Novartis NVS and Merck MRK.
Immunomedics, Inc. Price
Immunomedics, Inc. price | Immunomedics, Inc. Quote
Immunomedics currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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