On December 16, 2015 Celsion Corporation (NASDAQ: CLSN) reported that it has received Clinical Trial Application (CTA) approval from the China Food and Drug Administration (CFDA) to conduct the ongoing Phase III OPTIMA Study at clinical sites in China (Press release, Celsion, DEC 16, 2015, View Source [SID:1234508584]). Schedule your 30 min Free 1stOncology Demo! The OPTIMA Study is the Company’s global pivotal, double-blind, placebo-controlled trial, evaluating ThermoDox, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, in combination with radiofrequency ablation standardized to 45 minutes (sRFA) versus sRFA alone to treat patients with primary liver cancer, also known as hepatocellular carcinoma (HCC). Celsion Corporation is a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies for the treatment of cancer and other difficult-to-treat diseases.
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"The OPTIMA Study is the only global Phase III clinical trial being conducted in HCC, and the China market is an important element of our global development strategy for ThermoDox, representing approximately 50% of the 850,000 new cases of primary liver cancer diagnosed each year," noted Michael H. Tardugno, Celsion’s chairman, president and chief executive officer. "We believe that this approval by the China FDA represents another important validation of our development program for ThermoDox, which shows the potential for improvement in overall survival in HCC patients. This approval also positions us as a leader in research in a major global market for primary liver cancer," Mr. Tardugno said.
The Phase III OPTIMA Study is expected to enroll up to 550 patients globally, and has been successfully enrolling patients at 50 clinical sites in 12 different countries in North America, Europe and Asia Pacific. The CTA approval will now allow Celsion to enroll patients at up to 25 additional clinical sites in China. With the addition of these Chinese clinical sites, the Company expects to complete enrollment in the OPTIMA Study by the end of 2017. Results from the OPTIMA Study, if successful, will provide the basis for a global registration filing and marketing approval.
The primary endpoint for the OPTIMA Study is overall survival (OS). The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC). The design of the OPTIMA Study is supported by a retrospective analysis of a large subgroup of 285 patients in the Company’s previous 701 patient HEAT Study in primary liver cancer. In a subgroup of 285 HEAT Study participants, ThermoDox plus standardized RFA demonstrated a statistically significant improvement in survival of over two years compared to standardized RFA alone. In this large subgroup, the median OS in the ThermoDox plus standardized RFA arm was approximately 80 months, which is considered a curative treatment for HCC.
"There is significant interest in the curative potential for ThermoDox among leading liver cancer experts in China and the world, and we have a number of highly-motivated sites eager to enroll patients in this important study," Mr. Tardugno added. "We are aggressively recruiting patients worldwide, and look forward to building our relationships with these key study sites in China as the trial progresses."
Array BioPharma Announces Phase 3 Binimetinib Trial Meets Primary Endpoint For NRAS-Mutant Melanoma
On December 16, 2015 Array BioPharma (Nasdaq: ARRY) reported top-line results from the ongoing Phase 3 clinical trial of binimetinib in patients with advanced NRAS-mutant melanoma, known as the NEMO trial (Press release, Array BioPharma, DEC 16, 2015, View Source [SID:1234508583]). Schedule your 30 min Free 1stOncology Demo! The study met its primary endpoint of improving progression-free survival (PFS) compared with dacarbazine treatment. The median PFS on the binimetinib arm was 2.8 months versus 1.5 months on the dacarbazine arm; hazard ratio (HR) 0.62, [95% CI 0.47-0.80], p < 0.001.
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In the trial, binimetinib was generally well-tolerated and the adverse events reported were consistent with previous results in NRAS melanoma patients.
Array plans to submit binimetinib to regulatory authorities for marketing approval in NRAS-mutant melanoma during the first half of 2016. Results from the NEMO trial including progression free survival, overall survival, objective response rate, safety and prespecified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at a medical meeting in 2016.
"We are excited to announce positive results from the NEMO trial, which suggest binimetinib has the potential to provide an important new treatment option for patients with advanced NRAS melanoma," said Ron Squarer, Chief Executive Officer, Array BioPharma. "We look forward to discussing the data with the FDA and other regulatory agencies in the near future."
"The presence of an NRAS mutation is a poor prognostic indicator for patients with advanced melanoma," said Keith T. Flaherty, M.D., Associate Professor, Medicine, Harvard Medical School and Director of Developmental Therapeutics, Cancer Center, Massachusetts General Hospital. "I am encouraged the NEMO trial met its primary endpoint and look forward to sharing the full results soon. As the first targeted therapy with positive results in NRAS melanoma, binimetinib will be a welcome addition in this high unmet need population, especially for patients whose disease has progressed following treatment with immunotherapy."
Binimetinib is also being studied in the Phase 3 COLUMBUS trial for patients with BRAF-mutant melanoma and the Phase 3 MILO trial for patients with low grade serous ovarian cancer, as well as in several other earlier stage clinical trials.
About NEMO
The NEMO trial, (NCT01763164), is an international, randomized Phase 3 study in patients with advanced NRAS-mutant melanoma. 402 patients were randomized 2:1 to receive continuous 45 mg BID binimetinib or 1,000 mg/m2 dacarbazine dosed every three weeks. Prior immunotherapy treatment was allowed. The primary endpoint of the study is progression free survival, and overall survival is a key secondary endpoint. Patients underwent radiographic assessment of disease status every six weeks, and assessment of progression was determined by blinded central review. Over 100 sites across North America, Europe, South America, Asia and Australia participated in the study.
About Binimetinib
MEK is a key protein kinase in the RAS/RAF/MEK/ERK pathway. Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, migration, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as non-small cell lung cancer, melanoma, colorectal, ovarian and thyroid cancers. Binimetinib is a small molecule MEK inhibitor which targets key enzymes in this pathway. Binimetinib is being studied in three active Phase 3 trials in advanced cancer patients, including: NRAS-mutant melanoma (NEMO), low-grade serous ovarian cancer (MILO) and BRAF-mutant melanoma (COLUMBUS).
About NRAS Melanoma
Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with almost 74,000 new cases and nearly 10,000 deaths from the disease projected in 2015. NRAS mutations occur in approximately 15% to 20% of patients with melanoma, and is known to be a poor prognostic factor. When melanoma is diagnosed early, it is generally a curable disease. However, when it spreads to other parts of the body, it is the deadliest and most aggressive form of skin cancer. Historically, a person with metastatic melanoma typically has a short life expectancy with NRAS melanoma patients living an average of 8.5 months from diagnosis.
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Spectrum Pharmaceuticals Announces Agreement with FDA on the Special Protocol Assessment (SPA) for the Registrational Trial of SPI-2012, a Novel, Long Acting G-CSF in Patients with Breast Cancer
On December 16, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations, and a primary focus in Hematology and Oncology, reported that the company has reached agreement with the U.S. Food and Drug Administration (FDA) on the Special Protocol Assessment (SPA) for the Phase 3 clinical trial of its novel, long-acting G-CSF, SPI-2012 (eflapegrastim) (Press release, Spectrum Pharmaceuticals, DEC 16, 2015, View Source [SID:1234508582]). Schedule your 30 min Free 1stOncology Demo! This trial will evaluate the safety and efficacy of SPI-2012 as a treatment for chemotherapy-induced neutropenia in patients with breast cancer, and will serve as the basis for the Biologics License Application (BLA) filing.
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"We are excited to have reached agreement with the FDA on the SPI-2012 SPA, which is the highest priority program at Spectrum," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "SPI-2012 is a novel proprietary biologic that has been shown in a Phase 2 clinical trial to be more potent than pegfilgrastim, and consists of a novel, recombinant G-CSF conjugated, using a technology that enhances the half-life of this therapeutic protein. Our team has been ready to start this registrational Phase 3 trial, and plans to aggressively drive study enrollment. Spectrum has built a strong clinical team and commercial infrastructure with expertise in the treatment of neutropenia. If approved, we believe this drug will enable us to compete in a blockbuster market and change the face of our Company."
In accordance with the SPA, this registrational, Phase 3 trial, or ADVANCE study (RAnDomized Trial of SPI-2012 Versus Pegfilgrastim in the Management of Chemotherapy Induced Neutropenia in Breast CANCEr Patients Receiving Docetaxel and Cyclophosphamide) will be a multicenter, randomized, active controlled trial that will enroll 580 newly diagnosed early-stage breast cancer patients, who will receive adjuvant or neoadjuvant chemotherapy every 21 days. Adjuvant chemotherapy is treatment given after primary surgical therapy to kill any remaining cancer cells and increase the chance of long-term disease-free survival; neoadjuvant chemotherapy is the administration of cytotoxic agents before surgical resection in early-stage breast cancer to shrink the tumor and potentially allow for breast-conserving surgery. SPI-2012 will be administered subcutaneously as a fixed dose equivalent to 3.6 mg of GCSF, which was selected based on the robust pharmacological and pharmacodynamic data from Phase 2. The primary study endpoint is the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] < 0.5×109/L) in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. Secondary endpoints include the Incidence of Neutropenic Complications, Incidence of Febrile Neutropenia, Relative Dose Intensity, and safety.
About Special Protocol Assessments
A Special Protocol Assessment is a written agreement between a Sponsor and the U.S. Food and Drug Administration on the design, execution and analysis for a clinical trial that may form the basis of a new Biologics License application or BLA. Final marketing approval depends upon the efficacy results, safety profile and an evaluation of the risk/benefit of treatment demonstrated in the Phase 3 clinical program.
About Breast Cancer
According to the American Cancer Society (ACS), breast cancer is the second most common form of cancer in women after skin cancer, and the second highest cause of female cancer deaths after lung cancer. Unfortunately, it is estimated that about 1 in 8 (12%) of women in the US will develop invasive breast cancer during their lifetime. In 2015 in the United States (US), an estimated 231,840 new cases of invasive breast cancer and 60,290 additional cases of in situ breast cancer will be diagnosed, and approximately 40,290 US women are expected to die from breast cancer. In addition, ~2,350 men are also expected to be diagnosed with breast cancer in 2015 with an estimated 440 deaths.
FDA Lifts Advaxis Clinical Hold
On December 16, 2015 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac (formerly ADXS-HPV), ADXS-PSA and ADXS-HER2 (Press release, Advaxis, DEC 16, 2015, View Source [SID:1234508580]). Advaxis will therefore resume all clinical trials with axalimogene filolisbac, ADXS-PSA and ADXS-HER2. Schedule your 30 min Free 1stOncology Demo! "We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials," said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.
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In October of 2015, Advaxis received notification from the FDA that its IND applications for axalimogene filolisbac were put on clinical hold in response to the company’s submission of a safety report to the FDA. The clinical hold also included the INDs for ADXS-PSA and ADXS-HER2. Following discussions with the FDA and in accordance with their recommendations, the company agreed to implement certain risk mitigation measures, including revised study protocol inclusion / exclusion criteria, post-administration antibiotic treatment and patient surveillance and monitoring measures.
About Axalimogene Filolisbac
Axalimogene filolisbac (ADXS-HPV) is Advaxis’s lead Lm Technology immunotherapy candidate for the treatment of HPV-associated cancers and is in clinical trials for three potential indications: invasive cervical cancer, head and neck cancer, and anal cancer. In a completed randomized Phase 2 study in recurrent/refractory cervical cancer, axalimogene filolisbac showed apparent prolonged survival, objective tumor responses, and a manageable safety profile alone or in combination with chemotherapy, supporting further development of the company’s Lm Technology.
About ADXS-PSA
ADXS-PSA is an Lm Technology immunotherapy under investigation for targeting the prostate-specific antigen (PSA) associated with prostate cancer. ADXS-PSA is in clinical development both as a monotherapy and in combination with immune checkpoint inhibitors for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
About ADXS-HER2
ADXS-HER2 is an Lm Technology immunotherapy product candidate being developed by Advaxis to target HER2 expressing cancers. ADXS-HER2 has received orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of osteosarcoma. Advaxis is developing ADXS-HER2 for both human and animal health, and has seen encouraging data in canine osteosarcoma, which is considered a model for human osteosarcoma. Advaxis has licensed ADXS-HER2 and three other immunotherapy constructs to Aratana Therapeutics, Inc. for the development of pet therapeutics.
FDA Approves Expanded Age Indication for GARDASIL® 9 in Males
On December 15, 2015 Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded age indication for GARDASIL9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11 (Press release, Merck & Co, DEC 15, 2015, View Source [SID1234607429]). GARDASIL 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. GARDASIL 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
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"This is an important approval that now aligns the indication for GARDASIL 9 in males and females ages 9 through 26 to that of GARDASIL, and also supports the CDC’s HPV vaccine recommendations for use in males," said Jacques Cholat, M.D., president, Merck Vaccines. "We are pleased that males 16 through 26 years of age will now have access to GARDASIL 9, which includes the most HPV types, to help further reduce the burden of HPV-related diseases."
GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) includes the greatest number of HPV types in any available HPV vaccine. GARDASIL 9 adds protection against five additional HPV types — 31, 33, 45, 52 and 58 — in addition to the four original HPV types covered by GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. Seven HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90-95 percent of HPV-related anal cancers, approximately 90 percent of cervical cancers, and approximately 80 percent of high-grade cervical lesions (cervical precancers, defined as CIN 2 and CIN 3) worldwide. These seven HPV types also cause 90 percent of HPV-related vulvar cancers and 85 percent of HPV-related vaginal cancers. HPV types 6 and 11 cause approximately 90 percent of genital warts cases in males and females.
Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.
CDC’s ACIP Recommendations
Following its February 2015 meeting, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) included GARDASIL 9 in the HPV vaccination recommendations, which added it to the routine recommendations for vaccination of males and females 11 and 12 years of age. The HPV vaccination series can be started at age nine. Only GARDASIL 9 and GARDASIL are indicated and recommended for use in males in the United States. The ACIP also recommends HPV vaccination for females 13 through 26 years of age and for males 13 through 21 years of age who have not been vaccinated previously or who have not completed the 3-dose series.
GARDASIL 9 is covered under the CDC’s Vaccines for Children (VFC) program for both boys and girls. Since 1994, the VFC program has provided vaccines to children through the age of 18 who are Medicaid-eligible, uninsured, underinsured, American Indian or Alaska Native.
"While it is important to remember that the CDC’s ACIP recommends routine HPV vaccination at age 11 or 12, before exposure to the HPV virus, this expanded indication for GARDASIL 9 is exciting because now 16- through 26-year-old young men can get this HPV vaccine," said Anna Giuliano, Ph.D., founding director, Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center & Research Institute, Tampa, and clinical investigator for GARDASIL 9. "It’s important that we collectively work to increase HPV vaccination rates to help prevent HPV-related cancers and diseases."
CDC Reports Low HPV Vaccination Rates, Especially for Males
In 2014, the CDC made increasing HPV vaccination rates a public health priority. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage is especially low in males. In 2014, for boys 13 through 17 years of age, coverage with at least one dose of HPV vaccine was just 41.7 percent, and receipt of the recommended three doses was even lower — just 21.6 percent.
A health care provider recommendation is very important in helping a parent decide to get their son or daughter vaccinated against HPV-related cancers and diseases, and the CDC encourages health care providers to routinely recommend HPV vaccination at 11 or 12 years of age with the same sense of importance used to recommend other adolescent vaccines in order to increase vaccination rates and help protect more individuals against HPV-related cancers and other diseases.
Availability and market transition information for GARDASIL 9 (Human
Papillomavirus 9-valent Vaccine, Recombinant)
GARDASIL 9 is available, and most managed care plans have already made decisions to cover the cost of GARDASIL 9, including for males 16 through 26 years of age, making the number of plans covering GARDASIL 9 similar to the number covering the cost of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. The approval of GARDASIL 9 for males 16 through 26 years of age is a milestone in the planned transition from GARDASIL to GARDASIL 9, as both products are now approved for the same populations.
The goal in the United States is to fully transition from use of GARDASIL to GARDASIL 9. Merck will ensure availability of and communication around GARDASIL and GARDASIL 9 to allow for a smooth transition.
GARDASIL 9 is available through Merck’s patient assistance program for vaccines. Through this program, Merck provides free vaccines to adults who are uninsured and who are unable to afford vaccines. More information can be found at www.MerckHelps.com.
Clinical Program for Immunogenicity and Safety of GARDASIL 9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) in Males 16 through 26
Years of Age
The clinical trial program for GARDASIL 9 was designed to build upon the safety and efficacy established in clinical trials with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. The pivotal efficacy study in females 16 through 26 years of age evaluated the efficacy of GARDASIL 9 to prevent HPV-related cervical, vulvar, and vaginal disease using GARDASIL as a comparator. Effectiveness of GARDASIL 9 against persistent infection and disease related to the nine vaccine HPV types in males 16 through 26 years of age was inferred from a non-inferiority comparison of type-specific antibody geometric mean titers (GMTs) following vaccination with GARDASIL 9 among heterosexual males 16 through 26 years of age with those among females 16 through 26 years of age.
A total of 1,106 heterosexual males and 1,101 females were enrolled in the study. The primary analyses were conducted in the per-protocol population, in which study participants received all three vaccinations within pre-defined day ranges, did not have major deviations from the study protocol, and were seronegative to the relevant HPV type(s) prior to dose one. The analyses found that anti-HPV GMTs at Month 7 among males 16 through 26 years of age were non-inferior to anti-HPV GMTs among females 16 through 26 years of age.
In the clinical studies with GARDASIL 9 in males 16 through 26 years of age, the most common (≥10%) local and systemic adverse reactions reported were injection-site pain (63.4%), injection-site swelling (20.2%) and injection-site erythema (20.7%).
Important Information about GARDASIL 9
GARDASIL 9 does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.
Recipients of GARDASIL 9 should not discontinue anal cancer screening if it has been recommended by a health care provider.
GARDASIL 9 has not been demonstrated to provide protection against disease from vaccine HPV types to which a person has previously been exposed through sexual activity.
GARDASIL 9 has not been demonstrated to protect against diseases due to HPV types other than 6, 11, 16, 18, 31, 33, 45, 52, and 58.
GARDASIL 9 is not a treatment for external genital lesions; cervical, vulvar, vaginal, and anal cancers; CIN; VIN; VaIN; or AIN.
Not all vulvar, vaginal, and anal cancers are caused by HPV, and GARDASIL 9 protects only against those vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52 and 58.
Vaccination with GARDASIL 9 may not result in protection in all vaccine recipients.
Select Safety Information for GARDASIL 9 (Human Papillomavirus
9-valent Vaccine, Recombinant)
GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].
Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion by maintaining a supine or Trendelenburg position.
Dosage and administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid region of the upper arm or in the higher anterolateral area of the thigh at the following schedule: 0, 2 months, 6 months.
About HPV and related cancers and diseases
In the United States, HPV will infect most sexually active males and females in their lifetime. According to the CDC, there are approximately 14 million new genital HPV infections in the United States each year, half of which occur in people 15 through 24 years of age. For most people, HPV clears on its own, but for others who don’t clear the virus, it could lead to significant cancers and other diseases in males as well as females, and there is no way to predict who will clear the virus.
HPV causes approximately 85-90 percent of anal cancers in both males and females. According to the American Cancer Society, an estimated 2,600 men and 4,600 women in the United States will be diagnosed with anal cancer in 2015, and overall rates have been increasing. There is no routine screening recommended for the general population to reduce the risk of anal cancer.
HPV causes approximately 90 percent of genital warts in both males and females. There are approximately 360,000 cases of genital warts each year in the United States. Treatment of genital warts can be painful, and they may recur after treatment, especially in the first three months. Approximately 3 out of 4 people get them after having genital contact with someone who has genital warts.
In women, HPV also causes virtually all cervical cancer cases. Each day another 35 women are diagnosed with cervical cancer in the United States — about 12,900 women per year. HPV also causes approximately 70-75 percent of vaginal cancer cases and approximately 30 percent of vulvar cancer cases in females. Additionally, there are an estimated 3 million abnormal Pap results, many of which are caused by HPV, that require follow-up each year in the United States.