5/16/2023 0 Comments Her2 postie received zalota![]() Meanwhile, the hotel’s 31 light and airy rooms and suites have had their traditional décor complemented with vintage inspired textiles and original artwork, updated with modern air conditioning systems and the latest in-room technology. LobbyĪs part of the six-month renovation of The Strand Yangon, local artisans have meticulously restored every original architectural detail of The Strand Yangon, from the teak panelling and antique bedsteads, to traditional Myanmar lacquer ware and marble flooring. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.Myanmar’s grand dame hotel, The Strand Yangon, will reopen on 15th November 2016 after a restoration project that has seen this luxury heritage hotel ushered elegantly into the 21st century. The Strand Yangon was one of the first luxury colonial outposts to open in South East Asia, founded in 1901 by the famous hoteliers, the Sarkiesbrothers, and it remains one of the most architecturally beautiful landmarks in the region. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA granted approval of Phesgo to Genentech Inc. Patients who experience anaphylaxis (severe allergic reaction) or severe hypersensitivity should discontinue Phesgo. The FDA advises health care professionals to inform females of reproductive age that exposure to Phesgo during pregnancy or within 7 months prior to conception can result in fetal harm. Women who are pregnant should be advised that Phesgo may cause harm to a developing fetus or a newborn baby. Phesgo can cause worsening of chemotherapy induced neutropenia (low level of white blood cells). The most common side effects for patients taking Phesgo were alopecia (hair loss), nausea, diarrhea, anemia (reduced number of red blood cells) and asthenia (lack of energy). Health care professionals should use similar monitoring parameters as those used with IV pertuzumab and IV trastuzumab. Prescribing information for Phesgo includes a boxed warning to advise health care professionals and patients about the risk of potential heart failure, fetal harm and lung toxicity. The FDA’s approval was based on the results of a non-inferiority study in patients with HER2-positive early breast cancer, which demonstrated Phesgo had comparable efficacy and safety as IV pertuzumab and IV trastuzumab, except for administration-related reactions, which were higher with Phesgo due to the subcutaneous route of administration. The therapeutic components in Phesgo are the same as those in FDA-approved intravenous (IV) pertuzumab and IV trastuzumab. Phesgo contains a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase for injection under the skin. This application was approved about four months ahead of the FDA goal date.” At this critical time, we continue to expedite oncology product development. “As part of the FDA’s ongoing commitment to address the novel coronavirus pandemic, we continue to keep a strong focus on patients with cancer who constitute a vulnerable population at risk of contracting the disease. With a new administration route, Phesgo offers an out-patient option for patients to receive trastuzumab and pertuzumab,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Currently, most patients with HER2-positive breast cancer receive trastuzumab and pertuzumab at infusion centers. ![]() Phesgo is initially used in combination with chemotherapy and could continue to be administered at home by a qualified health care professional once the chemotherapy regimen is finished. Pertuzumab and trastuzumab bind to sites on HER2 and disrupt signaling to stop cancer cell growth. HER2-positive breast cancer, which makes up approximately one-fifth of breast cancers, has too much of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. Patients should be selected based on an FDA-approved companion diagnostic test. Food and Drug Administration approved Phesgo-a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf-for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer.
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