Articles from GSK plc

GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone (BVd) versus daratumumab in combination with bortezomib plus dexamethasone (DVd) as a second line or later treatment for relapsed or refractory multiple myeloma. These data were featured today in an oral presentation at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition.

GSK plc (LSE/NYSE: GSK) today announced new preliminary data for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 18-49 at increased risk for lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) due to certain underlying medical conditions and in adults who are immunocompromised. These data show the vaccine’s potential to help protect a broader group of adults at risk from the potentially serious consequences of RSV. In the US alone, the number of adults aged 18-49 with at least one risk factor that could put them at risk for RSV disease could exceed 21 million.1

GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy and safety of a single dose of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, including those at increased risk, over three full RSV seasons (NCT04886596).1 These data will be presented today at the CHEST 2024 Annual Meeting, organized by the American College of Chest Physicians.

GSK plc (LSE/NYSE: GSK) today announced positive topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) when co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted), both AS01-adjuvanted vaccines (NCT05966090).1,2 The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress in Valencia, Spain (September 18-20th, 2024).2 SHINGRIX is approved for the prevention of shingles (herpes zoster) in adults aged 50 years and older. AREXVY is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel (chemotherapy) followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer. This approval broadens the previous indication for Jemperli plus chemotherapy to include patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) tumors who represent 70-75% of patients diagnosed with endometrial cancer and who have limited treatment options. The supplemental Biologics License Application (sBLA) supporting this expanded indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.

GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2024-25 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA).

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. In the US, the vaccine is currently approved for use in adults aged 60 and older and recommended by CDC/ACIP using shared clinical decision-making.

GSK plc (LSE/NYSE: GSK) today announced updated, longer-term results from the phase II supported collaborative study with Memorial Sloan Kettering Cancer Center (MSK) evaluating Jemperli (dostarlimab-gxly) as a first-line treatment—as an alternative to surgery—for mismatch repair deficient (dMMR) locally advanced rectal cancer. The trial showed an unprecedented 100% clinical complete response rate (cCR) in 42 patients who completed treatment with dostarlimab-gxly, defined as complete pathologic response or no evidence of tumors as assessed by magnetic resonance imaging, endoscopy and digital rectal exam. In the first 24 patients evaluated, a sustained clinical complete response with a median follow-up of 26.3 months (95% CI: 12.4-50.5) was observed.

GSK plc (LSE/NYSE: GSK) today announced positive results from an interim analysis of the DREAMM-8 phase III head-to-head trial evaluating belantamab mafodotin, in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex, as a second line and later treatment for relapsed or refractory multiple myeloma. These late-breaking data, being presented today at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (May 31 – June 4) in Chicago, IL, were featured in the official ASCO press program and simultaneously published in the New England Journal of Medicine.

GSK plc (LSE/NYSE: GSK) today announced statistically significant and clinically meaningful overall survival (OS) results from Part 1 and progression-free survival (PFS) results from Part 2 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial in adult patients with primary advanced or recurrent endometrial cancer. These data were presented today in a late-breaking plenary session at the Society of Gynecologic Oncology 2024 Annual Meeting on Women’s Cancer (March 16-18).

GSK plc (LSE/NYSE: GSK) today announced additional funding and new data and resources under the COiMMUNITY Initiative to help achieve higher adult vaccination rates and health equity in the US and address ongoing barriers to adult immunization. The COiMMUNITY Initiative complements recent industry and regulatory efforts to expand and improve adult vaccine availability, coverage and access.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted under Priority Review an application to extend the indication of GSK’s adjuvanted respiratory syncytial virus (RSV) vaccine to adults aged 50-59 who are at increased risk for RSV disease. If approved, GSK’s RSV vaccine would be the first vaccine available to help protect this population. AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is currently approved in the US in adults aged 60 and over for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

GSK plc (LSE/NYSE: GSK) today announced the recipients of the inaugural grant program of the COiMMUNITY Initiative, a multipronged effort to support the design of a more systematic, collaborative and equitable approach to helping increase adult immunization rates in the US. Each grant-funded project is receiving between $50,000 and $175,000 out of a total $1 million in funding to help address long-standing barriers to adult immunization in the US.

GSK plc (LSE/NYSE: GSK) has partnered with former Queer Eye star and interior designer Thom Filicia to launch Mapping Myelofibrosis, a new health education initiative aiming to help those impacted by myelofibrosis (MF) better navigate the disease. This year marks the 10-year anniversary of Filicia donating bone marrow to his brother, who was diagnosed with MF a few months prior to the transplant. Filicia now looks to use his voice to help raise awareness of this blood cancer, which can be difficult to diagnose and manage.1

GSK plc (LSE/NYSE: GSK) today announced positive preliminary results from its phase III trial [NCT05590403] evaluating the immune response and safety of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50 to 59, including those at increased risk of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) due to certain underlying medical conditions. These results will be presented at the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting on October 25, 2023. This vaccine is currently approved in the US for active immunization for the prevention of RSV-LRTD in adults 60 years of age and older. It is also approved in Europe, Japan, and several other countries.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. To date, it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms, and splenomegaly (enlarged spleen).4

GSK plc (LSE/NYSE: GSK) and YMCA of the USA will host GSK’s Sideline RSV “Community Conversations” event series as part of their campaign efforts to raise awareness about RSV infection in older adults. The events will take place at four YMCA locations across the country (Chicago, Los Angeles, New York City and Phoenix), joined by GSK’s campaign spokesperson Earvin “Magic” Johnson, to help spark important conversations about RSV, a common, contagious respiratory virus.1,2 Kicking off in September and running through RSV Awareness Month in October, the private events will include perspectives from medical professionals, and patients and convene public health leaders, media, and 60+ YMCA members.

GSK plc (LSE/NYSE: GSK) today announced that AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) is now available in the US at all major retail pharmacies. In June, the Advisory Committee on Immunization Practices (ACIP) recommended that persons 60 years of age and older may receive a single dose of RSV vaccine, using shared clinical decision making. Shared clinical decision making empowers patients, in consultation with their healthcare providers, to decide whether RSV vaccination is appropriate for them. AREXVY is indicated for the prevention of RSV-lower respiratory tract disease (LRTD) in individuals aged 60 years and older.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). The supplemental Biologics License Application (sBLA) supporting this new indication received Priority Review and was approved ahead of the Prescription Drug User Fee Act action date.

GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2023-24 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA).

GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favor of recommending the use of AREXVY (respiratory syncytial virus vaccine, adjuvanted) in adults aged 60 and older using shared clinical decision making. Shared clinical decision making empowers patients in consultation with their healthcare providers to determine whether RSV vaccination is appropriate for them.

GSK plc (LSE/NYSE: GSK) today announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of AREXVY (respiratory syncytial virus vaccine, adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older over multiple RSV seasons and after annual revaccination.

GSK plc (LSE/NYSE: GSK) announced today the launch of a new short film in collaboration with Lifetime that raises awareness among parents of teens and young adults about meningitis B vaccination, and the potential risks of meningitis B. The film, entitled “I Never Thought to Ask: A Mom's Quest for Answers” with Soleil Moon Frye Brought to You By GSK” takes viewers on a journey of discovery, as Soleil connects with a medical professional, and individuals and families affected by the disease – learning about important questions parents can ask their teen’s doctor.

GSK plc (LSE/NYSE: GSK) today announced the launch of the COiMMUNITY Initiative to help reduce health inequities and set a new precedent for adult immunization rates in the US, which continue to remain below pre-pandemic levelsi. The initiative is a multipronged effort to address long-standing barriers to adult immunization in the US with funding, increased data transparency through enhanced Vaccine Track capabilities and collaborations, and resource-sharing opportunities.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

GSK plc (LSE/NYSE: GSK) has partnered with Earvin “Magic” Johnson to launch Sideline RSV, a new health education campaign aimed to help older adults and their loved ones better understand the risks and potential seriousness of RSV infection and how to help protect themselves.

GSK plc (LSE/NYSE:GSK) today announced new 48-week data from the MOMENTUM phase III trial that showed a majority of patients treated with investigational momelotinib maintained their responses across key clinical measures including Total Symptom Score (TSS), Transfusion Independence (TI) rate, and Splenic Response Rate (SRR) in myelofibrosis patients previously treated with an approved Janus kinase (JAK) inhibitor. Additionally, new analyses from MOMENTUM showed that TI response with momelotinib at week 24 was associated with overall survival. These data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (10-13 December) in New Orleans.

GSK plc (LSE/NYSE: GSK) today announced the launch of Vaccine Track, a comprehensive platform developed by GSK and IQVIA for use by public health officials, industry leaders and medical professionals to strengthen vaccination data transparency, raise awareness and publicly share vaccination trends to aid improvements in routine adult vaccinations to create healthier communities across the US. This resource will provide frequent and relevant data on trends to focus and enhance public health efforts.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Benlysta (belimumab) for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant.i The approval extends the current indication in the US to include both lupus and active LN for the intravenous formulation in the pediatric patient population.

GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its quadrivalent influenza vaccines to US healthcare providers and pharmacies in preparation for the 2022-23 season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research.

GSK plc today announced the first recipient of the Target the Future Think Tank Challenge £70,000 (equivalent to approximately $100,000) grant to the HealthTree Foundation, a non-profit organization helping patients learn more about their health and become their own best advocates. Their proposal, the “HealthTree Equity and Diversity for Multiple Myeloma Program,” will improve access, education and support for underserved communities and minority patients.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved PRIORIX (Measles, Mumps and Rubella Vaccine, Live) for active immunisation for the prevention of measles, mumps and rubella (MMR) in individuals 12 months of age and older.