FDA Grants Fast Track for Triple Negative Drug

mike3121

See link to article on FDA fast track of Immu 132. Fast track means that the drug performed so well in Phase 1 & 2 that it can go right into production and general use. If this information has already been posted I'm sorry and can be deleted.

http://www.healio.com/hematology-oncology/breast-cancer/news/online/%7Ba2feabdf-3d34-4396-8ec9-504c0afd538d%7D/fda-grants-breakthrough-therapy-designation-to-immu-132-for-triple-negative-breast-cancer

Wife NED so far these last six months. Had ER+ in breast and Metaplastic in lymph nodes. Medium sized kidney tumor was benign. She's tolerating tamoxifen well.

JohnSmith

Thanks. Adding more detail...

Sacituzumab govitecan (IMMU-132), an anti-Trop-2 Antibody-Drug Conjugate (ADC) has received an FDA breakthrough therapy designation for the treatment of patients with TNBC following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer.

The designation, which will expedite the development and review of IMMU-132 in TNBC, is based on a phase II trial in which the therapy induced a response rate of 31% in heavily pretreated patients with metastatic TNBC.

"We believe breakthrough therapy designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition," Cynthia Sullivan, CEO of Immunomedics, said in a statement. "We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the special protocol assessment agreement that was already granted by the FDA," she added.

Sacituzumab govitecan is a humanized IgG antibody targeted against Trop-2 conjugated to SN-38, which is an active metabolite of the chemotherapy irinotecan (Aka: Camptosar, Campto).
Trop-2 is expressed in more than 90% of TNBC.

JohnSmith

Update from the 2016 SABCS conference:

http://www.onclive.com/conference-coverage/sabcs-2016/sacituzumab-govitecan-elicits-durable-responses-for-pretreated-tnbc

Treatment with sacituzumab govitecan (IMMU-132) was well-tolerated and induced durable responses, some lasting longer than 1 year, for heavily pretreated patients with metastatic triple-negative breast cancer (TNBC), according to findings from an ongoing phase I/II study presented at the 2016 San Antonio Breast Cancer Symposium.

In the single-arm trial, the confirmed objective response rate (ORR) was 30% with sacituzumab govitecan, and the duration of response was 8.9 months (95% CI, 6.1-11.3).
The median progression-free survival was 6.0 months (95% CI, 5.0-7.3) and the median overall survival was 16.6 months (95% CI, 11.1-20.6).

"The findings are truly outstanding," said senior study author Linda Vahdat, MD, MBA, from Weill Cornell Medical College.
"The confirmed response rate is near 30%, and what's really striking is that this is a group of patients with a median of 5 prior regimens for breast cancer—it is a very heavily pretreated population."

The ongoing study enrolled 69 patients with relapsed/refractory metastatic TNBC.

"These aren't just flash in the pan type of responses, they are actually quite durable," said Vahdat.
"When you have a drug that you can keep someone on in triple-negative breast cancer for almost a year you get excited, because the median survival in TNBC is a little under a year."

A phase III study is currently being planned under a special protocol agreement with the FDA.