On October 25, 2017 Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) reported that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1) (Press release, Incyte, OCT 25, 2017, View Source;p=RssLanding&cat=news&id=2310980 [SID1234521152]). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.

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"Anti-PD-1 therapy is becoming a mainstay of cancer treatment across multiple tumor types, and we believe the addition of MGA012 to our clinical pipeline is important to fulfilling our long-term development strategy in immuno-oncology. This collaboration with MacroGenics will allow us to rapidly explore the potential clinical benefit of developing MGA012 as a monotherapy and also combining anti-PD-1 therapy with several of our existing portfolio assets," said Steven Stein, M.D., Chief Medical Officer of Incyte.

"We believe Incyte is the ideal partner for MGA012, given its immuno-oncology portfolio and dedication to researching and developing innovative and transformative cancer therapies and we hope that the combined resources of both companies will be able to significantly expand and accelerate the current development efforts for this promising molecule," said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. "Furthermore, we look forward to exploring the combination of MGA012 with multiple molecules in our own portfolio, including DART molecules for redirected T-cell killing, antibodies with enhanced effector function and ADCs, potentially to provide improved patient benefit."

Enrollment in the dose escalation portion of the Phase 1 study of MGA012 has been completed and the molecule is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the study. Data from the dose escalation portion of the Phase 1 study have been accepted for poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.

Terms of the Collaboration
Upon closing, Incyte will pay MacroGenics an upfront payment of $150 million. Incyte will receive worldwide rights to develop and commercialize MGA012 in all indications.

Per the terms of the collaboration, MacroGenics will also be eligible to receive up to $420 million in potential development and regulatory milestones, and up to $330 million in potential commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte.

Under the terms of the collaboration, Incyte will lead global development of MGA012. MacroGenics retains the right to develop its pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its asset(s), if any such potential combinations are approved.

In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. MacroGenics intends to utilize its commercial-scale GMP facility, which is expected to be fully operational in 2018.

The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.

On October 25, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in hard-to-treat cancers, reported that the Company will participate in the Life Sciences Summit 2017 on November 1-2 in New York City and the Jefferies 2017 London Healthcare Conference on November 15-16 (Press release, 2X Oncology, OCT 25, 2017, View Source [SID1234526101]).

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Chief Executive Officer George O. Elston will participate in and hold 1x1s with investors at both conferences, joined by Chief Financial Officer Jarne Elleholm.

Additionally, Mr. Elston will present in the Emerging Company Showcase at the Life Sciences Summit on Thursday, November 2, 2017 at 3:30pm EDT, with a discussion period to follow.

Investors wishing to meet with 2X Oncology at or around either conference should notify the respective conference one-on-one desk, or contact Amy Raskopf to schedule a meeting.

On October 25, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, "Perjeta I.V. Infusion 420mg/14mL [generic name: pertuzumab (genetical recombination)] (hereafter, Perjeta)" for the additional indication of adjuvant therapy for HER2-positive early breast cancer (Press release, Chugai, OCT 25, 2017, View Source [SID1234521138]).

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"Currently, adjuvant chemotherapy with Herceptin for HER2-positive early breast cancer has been recommended in the clinical practice guidelines for breast cancer and has contributed to patients," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "We are going to continue discussions with the health authorities so that adjuvant chemotherapy using Perjeta in combination with Herceptin, which has outperformed the current standard of care, will be used as a new treatment option for patients."

Chugai filed the application with the MHLW based on the results from the APHINITY study (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer) and several clinical studies. The APHINITY study is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy (anthracycline medicine followed by docetaxel monotherapy / docetaxel plus carboplatin) compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 patients with HER2-positive early breast cancer who undergone curative surgery. The primary endpoint of the APHINITY study is invasive disease-free survival (iDFS), which is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. The secondary endpoints were cardiac and overall safety, and other endpoints.

The results of the APHINITY study are as follows:

– At three years, iDFS, the primary endpoint, was 94.1% in the Perjeta arm and 93.2% in the control arm, and a statistically significant improvement was observed in the Perjeta arm. Perjeta arm significantly reduced the risk of recurrence or death by 19% compared to control arm (HR=0.81, 95%CI 0.66-1.00, stratified log-rank test, p=0.045).

– The iDFS at four years estimated by the Kaplan-Meier method showed that 92.3% (95%CI: 91.1-93.4) of people treated with the Perjeta arm did not have their breast cancer return compared to 90.6% (95%CI: 89.3-91.8) treated with control arm.

– The safety profile of Perjeta was consistent with that seen in previous studies. The incidence of cardiac events was 0.7% in the Perjeta arm and 0.3% in the control arm.

In the US and Europe, Perjeta is under review for postoperative adjuvant chemotherapy for HER2-positive breast cancer, and the US Food and Drug Administration has granted Priority Review to Perjeta for this indication. Perjeta was approved for adjuvant therapy (before surgery) for HER2-positive early breast cancer in September 2013 in the US and in July 2015 in Europe.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work for early approval to provide Perjeta as a new treatment option for patients with HER2-positive early breast cancer.

On October 25, 2017 LabCorp (or the "Company") (NYSE: LH) reported results for the third quarter ended September 30, 2017, and increased its 2017 guidance (Press release, LabCorp, OCT 25, 2017, View Source;p=RssLanding&cat=news&id=2310992 [SID1234521154]).

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"We delivered record results highlighted by outstanding growth in the quarter, as revenue increased by 10%, adjusted EPS increased by 9%, and continued strong cash flow resulted in an increase of our full year free cash flow guidance to roughly $1 billion," said David P. King, chairman and CEO. "The Diagnostics business had strong organic and total volume growth despite the adverse impact from multiple hurricanes, and the Drug Development business turned in a solid performance, highlighted by improved margins, robust net orders, increased book-to-bill, and the closing of the Chiltern acquisition. We continue to expand our capabilities, broaden our geographic and customer base, deliver innovative solutions that only LabCorp can offer, and position ourselves for growth in the years ahead."

Consolidated Results

Third Quarter Results

Net revenue for the quarter was $2.60 billion, an increase of 9.5% compared to $2.37 billion in the third quarter of 2016. The increase in net revenue was due to growth from acquisitions of 6.9%, organic growth (net revenue growth less revenue from acquisitions for the first twelve months after the close of each acquisition) of 2.3%, and the benefit from foreign currency translation of approximately 30 basis points. In addition, revenue growth was negatively impacted by approximately 0.7% due to multiple hurricanes during the quarter.

Operating income for the quarter was $341.3 million, or 13.1% of net revenue, compared to $324.0 million, or 13.7%, in the third quarter of 2016. The increase in operating income was primarily due to acquisitions, organic revenue growth, and the LaunchPad business process improvement initiative, partially offset by higher personnel costs. The decline in operating margin was primarily due to restructuring charges, special items, and amortization totaling $105.2 million in the quarter, compared to $80.0 million during the same period in 2016. Adjusted operating income (excluding amortization of $54.6 million, as well as restructuring charges and special items of $50.6 million) for the quarter was $446.5 million, or 17.2% of net revenue, compared to $404.0 million, or 17.0%, in the third quarter of 2016.

Net earnings in the quarter were $180.6 million, compared to $179.5 million in the third quarter of 2016. Diluted EPS were $1.74 in the quarter, an increase of 1.8% compared to $1.71 in the same period in 2016. Adjusted EPS (excluding amortization, restructuring charges and special items) were $2.46 in the quarter, an increase of 9.3% compared to $2.25 in the third quarter of 2016. The Company’s adjusted earnings in the quarter were reduced by approximately $0.09 per diluted share due to the impact from multiple hurricanes.

Operating cash flow for the quarter was $350.9 million, compared to $249.9 million in the third quarter of 2016. The increase in operating cash flow was primarily due to higher cash earnings and improved working capital management. Capital expenditures totaled $75.3 million, compared to $66.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $275.6 million, compared to $183.7 million in the third quarter of 2016.

At the end of the quarter, the Company’s cash balance and total debt were $409.3 million and $7.2 billion, respectively. During the quarter, the Company invested approximately $1.2 billion in acquisitions, and repurchased $42.1 million of stock representing approximately 0.3 million shares. The Company had $447.4 million of authorization remaining under its share repurchase program at the end of the quarter.

Year-To-Date Results

Net revenue was $7.50 billion, an increase of 6.4% over last year’s $7.05 billion. The increase in net revenue was due to growth from acquisitions of 4.4%, and organic growth of 2.3%, partially offset by the impact of foreign currency translation of approximately 20 basis points.

Operating income was $1,010.0 million, or 13.5% of net revenue, compared to $989.0 million, or 14.0%, in the first nine months of 2016. The Company recorded restructuring charges and special items of $111.5 million in the first nine months of the year, compared to $82.7 million during the same period in 2016. The increase in operating income was primarily due to strong revenue growth and productivity, partially offset by higher personnel costs. The decline in operating margin was primarily due to higher amortization, restructuring charges and special items. Adjusted operating income (excluding amortization of $153.6 million, restructuring charges and special items) was $1.3 billion, or 17.0% of net revenue, compared to $1.2 billion, or 17.1%, in the first nine months of 2016.

Net earnings in the first nine months of 2017 were $561.4 million, or $5.40 per diluted share, compared to $547.7 million, or $5.25 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring charges and special items) were $7.14, an increase of 7.0% compared to $6.67 in the first nine months of 2016.

Operating cash flow was $895.4 million, compared to $727.0 million in the first nine months of 2016. The increase in operating cash flow was primarily due to higher cash earnings and lower working capital usage. Capital expenditures totaled $216.8 million, compared to $204.6 million in the first nine months of 2016. As a result, free cash flow (operating cash flow less capital expenditures) was $678.6 million, compared to $522.4 million in the first half of 2016.

***

The following segment results exclude amortization, restructuring charges, special items and unallocated corporate expenses.

Third Quarter Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.84 billion, an increase of 9.9% over $1.67 billion in the third quarter of 2016. The increase in net revenue was driven by acquisitions, organic volume (measured by requisitions excluding those from acquisitions for the first twelve months after the close of each acquisition), price, mix, and the benefit from foreign currency translation of approximately 20 basis points. Total volume (measured by requisitions) increased by 7.3%, of which organic volume was 2.3% and acquisition volume was 5.1%. Volume was negatively impacted by approximately 1.0% due to multiple hurricanes during the quarter. Revenue per requisition increased by 2.4%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $373.8 million, or 20.3% of net revenue, compared to $341.8 million, or 20.4%, in the third quarter of 2016. The increase in operating income was primarily due to strong revenue growth and LaunchPad savings. The 10 basis point decline in operating margin was due to the adverse impact from multiple hurricanes during the quarter. Excluding the impact from hurricanes, the operating margin would have increased 60 basis points over last year. During the quarter, the Company achieved its three-year goal to deliver $150 million in net LaunchPad savings.

Covance Drug Development

Net revenue for the quarter was $761.1 million, an increase of 8.6% over $701.1 million in the third quarter of 2016. The increase was primarily due to the acquisition of Chiltern, as well as organic growth and the benefit from foreign currency translation of approximately 60 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $108.9 million, or 14.3% of net revenue, compared to $95.5 million, or 13.6%, in the third quarter of 2016. The increase in operating income and margin were primarily due to the acquisition of Chiltern, organic revenue growth, cost synergies, and LaunchPad savings, partially offset by increased personnel costs. During the quarter, the Company achieved its three-year goal to deliver cost synergies of $100 million related to the acquisition of Covance. In addition, the Company remains on track to generate savings of approximately $20 million in 2017 (approximately $45 million on an annualized basis) from the expansion of the LaunchPad initiative to include Covance Drug Development.

Net orders and net book-to-bill during the trailing twelve months were $3.82 billion and 1.33, respectively. Backlog at the end of the quarter was $6.84 billion, which includes backlog from the Chiltern acquisition of $1.0 billion. The Company expects approximately $2.7 billion of this backlog to convert into revenue in the next twelve months.

Outlook for 2017

The following guidance assumes foreign exchange rates effective as of September 30, 2017 for the remainder of the year, and includes capital allocation.

Net revenue growth of 8.0% to 8.5% over 2016 net revenue of $9.44 billion, which includes the negative impact from approximately 10 basis points of foreign currency translation. This is an increase over the prior guidance of 5.0% to 6.5%.
Net revenue growth in LabCorp Diagnostics of 8.5% to 9.0% over 2016 net revenue of $6.59 billion. This is an increase over the prior guidance of 7.0% to 8.0% primarily due to the consolidation of a joint venture related to the acquisition of PAML.
Net revenue growth in Covance Drug Development of 6.0% to 7.5% over 2016 net revenue of $2.84 billion, which includes the negative impact from approximately 10 basis points of foreign currency translation. This is an increase over the prior guidance of 1.0% to 3.0% due to the acquisition of Chiltern.
Adjusted EPS of $9.40 to $9.60, an increase of approximately 6% to 9% as compared to $8.83 in 2016. This is an improvement over the prior guidance of $9.30 to $9.65.
Free cash flow (operating cash flow less capital expenditures) of $970 million to $1,010 million, an increase of approximately 8% to 13% over the prior year. This is an increase over the prior guidance of $925 million to $975 million due to continued strong earnings and working capital management.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including Adjusted EPS, Adjusted Operating Income, Free Cash Flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. Eastern Time and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 90788597. A telephone replay of the call will be available through November 8, 2017 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 90788597. A live online broadcast of LabCorp’s quarterly conference call on October 25, 2017 will be available at View Source or at View Source beginning at 9:00 a.m. Eastern Time. This webcast will be archived and accessible through October 19, 2018.

On October 25, 2017 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Avastin (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer (Press release, Genentech, OCT 25, 2017, View Source [SID1234521248]).

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"About 80 percent of women with ovarian cancer are diagnosed in the advanced stages when the disease is difficult to treat and options are limited," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are committed to working closely with the FDA to bring this potential new treatment option to women with newly diagnosed advanced ovarian cancer as soon as possible."

This sBLA for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the front-line treatment of people with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, is based on data from the pivotal Phase III GOG-0218 trial. In newly diagnosed advanced ovarian cancer, the first treatment a woman receives after surgery is known as front-line treatment. The FDA is expected to make a decision on approval by June 25, 2018.

This is part of our broader development program for Avastin in ovarian cancer. Avastin is currently approved for treating two different forms of advanced disease that recurred after platinum-based chemotherapy. In addition, Genentech is evaluating Avastin in combination with Tecentriq (atezolizumab) and chemotherapy for the treatment of newly diagnosed advanced ovarian cancer in the Phase III IMagyn050 trial (NCT03038100).

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind, placebo-controlled Phase III study in 1,873 women with previously untreated advanced epithelial ovarian, primary peritoneal, or fallopian tube carcinoma who already had surgery to remove as much of the tumor as possible. Participants were randomized into one of three treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin (15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus chemotherapy followed by Avastin alone. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone for a total duration of 22 cycles, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.64; 95% CI 0.54 – 0.77, p<0.0001). Secondary endpoints of the study included overall survival (OS) and objective response rate (ORR). Adverse events were consistent with those seen in previous trials of Avastin across tumor types for approved indications. The study was conducted by the Gynecologic Oncology Group (GOG) and their initial results were previously published in the New England Journal of Medicine.

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic cancer in the United States. In 2017, nearly 22,000 women will be diagnosed with ovarian cancer in the U.S. and more than 14,000 will die from the disease. About 80% of ovarian cancer cases are found at an advanced stage, when the cancer has spread beyond the ovaries. Early ovarian cancer often does not have any symptoms and when symptoms, such as abdominal swelling, bloating, abdominal pain, difficulty eating or feeling full quickly, and/or frequent urination, are present, they can be associated with other less serious conditions. Five-year survival rates worsen dramatically based on stage of diagnosis.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).

Avastin Indications:

Avastin is indicated for the first or second line treatment of patients with metastatic colorectal cancer in combination with intravenous 5 fluorouracil–based chemotherapy.
Avastin in combination with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin based chemotherapy is indicated for the second line treatment of patients with metastatic colorectal cancer who have progressed on a first line Avastin-containing regimen. Avastin is not indicated for adjuvant treatment of colon cancer.
Avastin in combination with carboplatin and paclitaxel chemotherapy is indicated for first line treatment of patients with unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small cell lung cancer.
Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix.
Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (psOC).
BOXED WARNINGS and Additional Important Safety Information

People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:

Gastrointestinal (GI) perforation:

Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine.
In clinical trials, this event occurred in more people who received Avastin than in the comparison group (up to 3.2%).
In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.
Surgery and wound healing problems:

Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality.
Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with metastatic colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15% for patients who received Avastin and 4% for patients who did not receive Avastin.
Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined.
Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that require medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.
Severe bleeding:

Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy.
Across cancer types, 0.4% to 6.9% of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.
Additional serious adverse events

In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group.

The formation of an abnormal passage in the body (GI and non-GI fistula formation) was seen in up to 2% of people in metastatic colorectal cancer and ovarian cancer patients. In a study of patients with cervical cancer, formation of an abnormal passage between the vagina and GI tract was seen in 8.3% of people.
Severe to life-threatening stroke or heart problems were seen in 2.6% of people.
Too much protein in the urine that led to kidney problems was seen in ≤1% of people.
Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included
Severe to life-threatening blood clots (VTE), up to 10.6%
Severe to life-threatening high blood pressure, which was seen in 5% to 18% of people
Nervous system and vision disturbances (Posterior Reversible Encephalopathy Syndrome), which was seen in less than 0.5% of people.
Infusion reactions with the first dose of Avastin were uncommon and occurred in less than 3% of people, and severe reactions occurred in 0.2% of people.
Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children. Avastin should not be used in ovarian cancer patients who have evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.
Patients who are pregnant, think they are pregnant, or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for six months following the last dose of Avastin. Avastin can cause fertility issues for women.

Women should be advised that breastfeeding while on Avastin may harm the baby and is therefore not recommended.

Common side effects that occurred in more than 10% of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis).

Across all trials, treatment with Avastin was permanently stopped in 8.4% to 21% of people because of side effects.

Report side effects to the FDA at (800) FDA-1088 or View Source . Report side effects to Genentech at (888) 835-2555.

For full Prescribing Information and Boxed WARNINGS on Avastin please visit View Source .