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FDA Approves Herceptin Hylecta

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.

HannaH, SafeHER and PrefHER study results

HannaH
	Herceptin Hylecta	Intravenous Herceptin
pCR (absence of invasive cancer cells in the breast)	45.4% (118/260) 95% CI 39.2%-51.7%	40.7% (107/263) 95% CI 34.7%-46.9%
Mean level of trastuzumab in the blood (C trough) before dosing eighth cycle	78.7 mcg/mL	57.8 mcg/mL
	Geometric mean ratio 1.3 (90% CI 1.2-1.4)
Most common adverse events (AEs; ≥10%)	Hair loss, nausea, administration-related reactions, feeling tired, decreased neutrophil count, diarrhea, rash, upper respiratory tract infection, vomiting, mouth blisters or sores, muscle pain, decreased appetite, constipation, radiation skin injury, damage to the nerves (numbness, tingling, pain in the hands/feet), joint pain, headache, flushing, fever, cough, low levels of red blood cells, difficulty breathing, incision site pain, low levels of white blood cells and mucosal inflammation
SafeHER
	Herceptin Hylecta n=1,864
Safety	No new safety signals for Herceptin Hylecta were identified. Safety and tolerability were consistent with the known safety profiles of intravenous Herceptin and Herceptin Hylecta.
Most common AEs (≥10%)	Administration-related reactions, feeling tired, diarrhea, injection site reaction, weakness, joint pain, rash, muscle pain, nausea, damage to the nerves (numbness, tingling, pain in the hands/feet), headache, swelling, flushing, fever, cough and pain in extremity
PrefHER
	Herceptin Hylecta followed by intravenous Herceptin (n=121) or intravenous Herceptin followed by Herceptin Hylecta (n=119)
Patient preference	86% of people preferred Herceptin Hylecta, 13% preferred intravenous Herceptin, 1% had no preference
Reasons for preference	The most common reason for preferring Herceptin Hylecta was time savings (179/231). The most common reason for preferring intravenous Herceptin was fewer local injection reactions.

About HER2-Positive Breast Cancer

Breast cancer is the most common cancer among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20 percent of breast cancers are HER2-positive based on the result of a diagnostic test.

About Herceptin Hylecta

Herceptin Hylecta (subcutaneous Herceptin) is a combination of trastuzumab and Halozyme Therapeutics’ Enhanze® drug delivery technology. Trastuzumab is the same monoclonal antibody in intravenous Herceptin that targets the HER2 receptor, a protein found on the outside of many normal cells and in high quantities on the outside of cancer cells in HER2-positive cancers. Herceptin is designed to block HER2 signaling that is believed to play a role in tumor growth and survival. Binding of Herceptin to HER2 may also signal the body’s immune system to destroy the cancer cells. Halozyme’s Enhanze technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan, a glycosaminoglycan or chain of natural sugars in the body, to aid in the dispersion and absorption of other injected therapeutic drugs.

Herceptin Hylecta Indication Statements

Adjuvant Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is approved for the treatment of adults with early stage breast cancer that isHuman Epidermal growth factor Receptor 2-positive (HER2-positive) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high-risk feature.* Herceptin Hylecta can be used in several different ways:

As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as “AC® TH.”
With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as “TCH.”
Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

Patients are selected for therapy based on an FDA-approved test for trastuzumab.

*High risk is defined as ER/PR-positive with one of the following features: tumor size greater than 2 cm, age less than 35 years, or tumor grade 2 or 3.

Metastatic Breast Cancer

Herceptin Hylecta has two approved uses in adults with metastatic breast cancer:

Herceptin Hylecta in combination with the chemotherapy drug paclitaxel is approved for the first-line treatment ofHuman Epidermal growth factor Receptor 2-positive (HER2-positive) metastatic breast cancer.
Herceptin Hylecta alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

Important Safety Information

Possible serious side effects with Herceptin Hylecta

Not all people have serious side effects, but side effects with Herceptin Hylecta therapy are common.

Although some people may have a life-threatening side effect, most do not.

A patient’s doctor will stop treatment if any serious side effects occur.

Herceptin Hylecta is not for everyone. A patient should be sure to contact their doctor if they are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin Hylecta and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. A patient’s doctor will check for signs of heart problems before, during, and after treatment with Herceptin Hylecta.

Patients should contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than five pounds in 24 hours, dizziness or loss of consciousness.

SEVERE LUNG PROBLEMS , including:

Severe shortness of breath
Scarring of the lungs
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
A patient’s doctor may check for signs of severe lung problems when he or she examines the patient.

These signs usually happen within 24 hours after receiving Herceptin Hylecta.

A PATIENT SHOULD BE SURE TO CONTACT THEIR DOCTOR IF THEY:

ARE A WOMAN WHO COULD BECOME PREGNANT, OR MAY BE PREGNANT

Herceptin Hylecta may result in the death of an unborn baby or birth defects. Contraception should be used while receiving Herceptin Hylecta and for seven months after a patient's last dose of Herceptin Hylecta. If a patient is or becomes pregnant while receiving Herceptin Hylecta or within seven months after their last dose of Herceptin Hylecta, the patient is encouraged to report Herceptin Hylecta exposure to Genentech at (888) 835-2555.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving intravenous trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.

A patient’s doctor may check for signs of low white blood cell counts when he or she examines the patient.

Experience HYPERSENSITIVITY AND ADMINISTRATION-RELATED REACTIONS, which have been reported with Herceptin Hylecta. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. A patient’s doctor will monitor them for signs of these reactions. Patients should contact their healthcare provider immediately if they experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems or chest pain.

SIDE EFFECTS SEEN MOST OFTEN

The most common side effects seen in treatment of adjuvant breast cancer with Herceptin Hylecta were tiredness, joint pain, diarrhea, injection site reaction, upper respiratory tract infection, rash, muscle pain, nausea, headache, swelling, flushing, fever, cough and pain in extremity.

The most common side effects seen in treatment of metastatic breast cancer (based on intravenous trastuzumab) are fever, chills, headache, infection, congestive heart failure, insomnia, cough and rash.

A patient should contact their doctor immediately if they have any of the side effects listed above.

Patients are encouraged to report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please see the Herceptin Hylecta full Prescribing Information for additional Important Safety Information, including most serious side effects.

About Genentech in Breast Cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

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