FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

South San Francisco, CA -- February 28, 2019 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk) for subcutaneous (under the skin) injection for the treatment of certain people with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. This new treatment includes the same monoclonal antibody as intravenous Herceptin® (trastuzumab) in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin.

"Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences."

The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer:

• The Phase III HannaH study compared neoadjuvant (before surgery) and adjuvant (after surgery) Herceptin Hylecta to intravenous Herceptin, both in combination with chemotherapy. Subcutaneous administration of Herceptin Hylecta resulted in non-inferior levels of trastuzumab in the blood (pharmacokinetics) and non-inferior clinical efficacy (pathological complete response rate; pCR) compared to intravenous Herceptin.
• The Phase III SafeHER study of adjuvant Herceptin Hylecta identified no new safety signals, with safety and tolerability consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta.
• The PrefHER patient preference study of adjuvant Herceptin Hylecta followed by intravenous Herceptin, or the reverse sequence, found the majority (86 percent) of people preferred Herceptin Hylecta over intravenous Herceptin.

The most common side effects in people receiving Herceptin Hylecta for early breast cancer were feeling tired, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and pain in extremity.

For those who qualify, Genentech offers patient assistance programs for people prescribed Herceptin Hylecta by their doctor through Genentech Access Solutions. Please contact Genentech Access Solutions at (866) 422-2377 or visit http://www.Genentech-Access.com for more information.

https://www.gene.com/media/press-releases/14779/20...

{wow. That's big. It was my understanding that they had no intention of launching the sub-q product in the U.S.}

A Simple Blood Test Is as Effective as a Biopsy in Detecting Lung Cancer Mutations

http://time.com/5540396/cancer-blood-test-liquid-b...

February 27, 2019

Biopsies are a necessary burden for people with cancer. Taking a small sample of tissue and sending it through genetic and molecular analysis can help doctors not just diagnose cancer, but also learn more about its inner workings to find the best treatments based on which mutations are feeding the disease.

But tissue biopsies are invasive, and depending on where the tumors are in the body, they can be painful to obtain. For some people, there may not even be enough cancer tissue for doctors to get the answers they need.

In a press briefing previewing the upcoming American Association for Cancer Research annual meeting in Atlanta, researchers reported that a commercial blood test, called a liquid biopsy, was at least as effective as a tissue sample at identifying important mutations in non-small cell lung cancers.

{It's not breast cancer but this development is encouraging news for non-invasive testing.}

3D Mammo Better for Breast Ca Screening in Younger Women?

Better detection, lower recall, particularly among controversial age group

Breast cancers detected with 3D mammography were smaller and more likely to not have spread to local lymph nodes than those detected by screening with standard digital mammography, a retrospective found.

Specifically, 73.7% of screening-detected breast cancers were 1 cm or smaller and node negative with 3D mammography examination compared with 65.4% with standard mammography, and this improved specificity was most evident in women ages 40 to 49...

February 28, 2019

https://www.medpagetoday.com/radiology/diagnosticr...

doi:10.1001/jamaoncol.2018.7078

Prognostic and Clinical Significance of Syndecan-1 Expression in Breast Cancer

• This meta-analysis assessed the clinical significance of syndecan-1 (SDC1; also called CD138) expression in 1305 breast cancer patients from nine eligible studies.
• Increased SDC1 protein expression in breast cancer was significantly associated with worse prognosis in terms of disease-free and overall survival, and an aggressive phenotype was associated with negative ER expression and positive HER2 expression.

Thanks once again for the kind words and encouragement everyone!

Anxious789: I have not had time to research. I kind of think 6 rounds is standard of care. I assume we are talking about early stage vs. MBC? I took a quick look at NCCN guidelines and (to my surprise) did not see a number of rounds cited. Will check and post if I find anything useful.