Major HRT supplier sanctioned after whistleblowers raise concerns over patient safety
A group of employees from Theramex, which supplies HRT treatments to millions of patients in the UK, wrote a letter to the pharmaceutical regulator Association of the British Pharmaceutical Industry over allegations the company was not following regulatory standards and may 'jeopardise' patient safety.
The whistleblowers claimed some products featured inaccurate prescribing information and failed to highlight common side effects. They claimed they had been forced to contact the regulator after their attempts to raise issues internally were brushed off.
The company has now admitted it breached regulatory codes, amounting to 'bringing discredit upon, and reducing confidence in the pharmaceutical industry', according to an interim case report from the ABPI. It also failed to maintain high standards and provide accurate and up-to-date prescribing information, the report said.
Theramex is a global pharmaceutical company specialising in women's health products, such as hormone replacement therapy (HRT) and fertility treatments. Theramex UK is its London-based arm.
It supplies common HRT therapies including Evorel, Bijuve and Intrarosa. From April to June 2025, there were 760,000 prescriptions of Evorel and 2,748 prescriptions of Bijuve, according to data from the NHS Business Services Authority. In 2023-24, there were 2.8 million prescriptions of Evorel.
One employee wrote the complaint on behalf of a group, according to the complaint published by the Prescription Medicines Code of Practice Authority, which is part of the ABPI.
The complaint, filed in October 2024, said: 'We are a group of employees from various cross-functional teams at Theramex, and we are writing to express our growing concerns regarding the company's adherence to regulatory standards and the accountability of its leadership.
'While we have attempted to escalate these issues internally on numerous occasions, there has been a consistent lack of action or meaningful response, which leaves us with no choice but to seek external guidance and support.'
The complaint alleged that some of Theramex's products, such as Intrarosa and Evorel, had not had their prescribing information updated. In the case of Evorel, information for health professionals was 'incomplete' and did not include information on common side effects such as uterine spasms and vaginal infection, the letter claimed.
For another drug, the letter alleged that prescribing information had not been updated for five years.
The complaint warned: 'This oversight can lead to healthcare professionals (HCPs) not being fully informed of potential risks, which could jeopardise patient safety.'
The PMCPA panel found Theramix's 'failure to provide accurate and complete prescribing information was unacceptable'.
The employees also alleged the company failed to comply with regulators for clinical trial compliance warning. 'The lack of resources within Theramex's global headquarters to ensure compliance with these standards is alarming,' it said.
Finally, the letter alleged the company has a 'blame culture' that was 'deeply concerning.'
In response to the complaint, Theramex UK said it took its obligations under the ABPI code of practice 'very seriously' and launched an internal investigation.
It said that, although it had a process to update prescribing information, this was not sufficiently robust to ensure prescribing information was immediately updated.
The pharma company acknowledged it did not meet standards concerning this allegation and admitted that, at the time of the complaint, it did not have a process in place for clinical studies.
The employees' letter claimed it had tried to escalate matters to senior leaders within Theramex. The company claimed it was not aware of any of the matters having been escalated internally prior to them being reported to the regulator.
As part of the sanction, Theramex must provide written confirmation that it will cease practices that breach codes, pay a charge and advertise details of the case.
Theramex UK said it 'absolutely acknowledges' the recent ruling and 'respects the [regulator's] decision'. 'Of course, we remain fully committed to ensuring our practices align with the highest ethical standards and necessary steps and corrective measures have been taken,' it said.
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"Hearst Magazines and Yahoo may earn commission or revenue on some items through these links." Of the more than 47 million women in the world who begin the menopause transition each year, more than 70 percent of them will experience musculoskeletal symptoms—and 25 percent will be disabled by them. Those startling stats are based on research by Vonda Wright, MD, an orthopaedic sports surgeon and author of Unbreakable. And yet, many women that Dr. Wright sees in her practice are only aware of more-talked-about symptoms like night sweats, hot flashes, and brain fog. The musculoskeletal symptoms—which includes arthritis, tendonitis, and osteopenia, and are linked to the drop in estrogen that happens during menopause—seem to come as a surprise. '[Women] come into my office and, without prompting, they'll say, 'I don't know what's happening, but I feel like I'm falling apart because it's not just one body part, it's multiple body parts,'' Dr. Wright says. 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Approval based on INAVO120 data showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone1 Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need2-4 Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis5 Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment. 'Itovebi is the first treatment of its kind to improve survival outcomes for those living with PIK3CA-mutated, ER-positive advanced breast cancer,' said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'Therefore, the Itovebi-based regimen may help address an important unmet need for people with this subtype of breast cancer.' The approval is based on results from the phase III INAVO120 trial, published in the New England Journal of Medicine in October 2024, which showed a 57% reduction in the risk of disease worsening or death (progression-free survival [PFS]) with the Itovebi-based regimen compared with palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43; 95% CI: 0.32-0.59, p<0.001) in the first-line setting.1 The PFS benefit was consistent across all pre-specified subgroups and the Itovebi-based regimen was well tolerated, with no new safety signals observed.1 These results were reinforced by the INAVO120 final overall survival analysis that showed the Itovebi-based regimen reduced the risk of death by 33% (stratified HR=0.67; 95% CI: 0.48–0.94, p-value=0.0190 [boundary=0.0469]).5 Additionally, the treatment regimen substantially delayed the time to chemotherapy by approximately two years compared with palbociclib and fulvestrant alone (stratified HR=0.43; 95% CI: 0.30-0.60).5 These data were presented at the 2025 American Society of Clinical Oncology Annual Meeting and published in the New England Journal of Medicine in May 2025. Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III studies (INAVO121, INAVO122, INAVO123), all in PIK3CA-mutated, locally advanced or metastatic breast cancer in various combinations.6-8 We are exploring additional studies in breast cancer and other tumour types with the hope of providing the benefit of this targeted therapy to more people with PIK3CA mutations. About Itovebi TM (inavolisib)Itovebi is an oral, targeted treatment that has been shown to provide well-tolerated and durable disease control in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer, who often have a poor prognosis and are in urgent need of new treatment options.1,4,9 Itovebi has been designed to help minimise the overall burden and toxicity of treatment and is differentiated from other PI3K inhibitors due to its high potency and specificity for the PI3K alpha isoform versus other isoforms, and unique mechanism of action that facilitates the degradation of mutated PI3K alpha.10,11 In addition to the European Commission's approval, the Itovebi-based regimen is also approved for the treatment of adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer in the United States, Switzerland, Canada, Australia, United Arab Emirates, China and Taiwan, with data from INAVO120 under review with several other global health authorities. About the INAVO120 studyThe INAVO120 study [NCT04191499] is a phase III, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant versus placebo plus palbociclib and fulvestrant in people with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.12 The study included 325 patients, who were randomly assigned to either the investigational or control treatment arm.12 The primary endpoint is progression-free survival, as assessed by investigators, defined as the time from randomisation in the clinical trial to the time when the disease progresses, or a patient dies from any cause.12 Secondary endpoints include overall survival, objective response rate, and clinical benefit rate.12 Beyond INAVO120, Itovebi is currently being investigated in three company-sponsored phase III clinical studies in PIK3CA-mutated locally advanced or metastatic breast cancer in various combinations: in combination with fulvestrant versus alpelisib plus fulvestrant in HR-positive/HER2-negative breast cancer post cyclin-dependent kinase 4/6 (CDK4/6) inhibitor and endocrine combination therapy (INAVO121; NCT05646862).6 in combination with pertuzumab plus trastuzumab for subcutaneous injection (SC) versus pertuzumab plus trastuzumab for SC and optional physician's choice of endocrine therapy as a maintenance treatment in HER2-positive disease (INAVO122; NCT05894239).7 in combination with CDK4/6 inhibitor and letrozole versus placebo plus a CDK4/6 inhibitor and letrozole in the first-line setting in PIK3CA-mutated HR-positive/HER2-negative, endocrine-sensitive breast cancer (INAVO123; NCT06790693).8 About oestrogen receptor (ER)-positive breast cancerER-positive is a subtype of hormone receptor (HR)-positive breast cancer, the most prevalent type of all breast cancers, accounting for approximately 70% of cases.13,14 A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.15 People diagnosed with ER-positive and HR-positive metastatic breast cancer often face the risk of disease progression and treatment side effects, creating a need for additional treatment options.14,16,17 The PI3K signalling pathway is commonly dysregulated in HR-positive breast cancer, often due to activating PIK3CA mutations, which have been identified as a potential mechanism of intrinsic resistance to standard of care endocrine therapy in combination with cyclin-dependent kinase 4/6 inhibitors.9 About Roche in breast cancerRoche has been advancing breast cancer research for more than 30 years with the goal ofhelping as many people with the disease as possible. Our medicines, along with companiondiagnostic tests, have contributed to bringing breakthrough outcomes in human epidermal growth factor 2-positive and triple-negative breast cancers. 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 oestrogen receptor-positive breast cancer, which is a form of hormone receptor-positive breast cancer, the most prevalent type of all breast cancers.13,14 About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by Turner NC, et al. Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer. NEJM. 2024;391(17):1584-96.[2] Cizkova M, et al. Gene expression profiling reveals new aspects of PIK3CA mutation in ERalpha-positive breast cancer: major implication of the Wnt signaling pathway. PLoS One. 2010;30;5(12):e15647.[3] Schagerholm C, et al. PIK3CA mutations in endocrine-resistant breast cancer. Scientific Reports. 2024;14:12542.[4] Fillbrunn M, et al. PIK3CA mutation status, progression and survival in advanced HR+/HER2- breast cancer: a meta-analysis of published clinical trials. BMC Cancer. 2022;22(1):1002.[5] Jhaveri KL, et al. Overall Survival with Inavolisib in PIK3CA-Mutated Advanced Breast Cancer. 2025;40454641.[6] A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (INAVO121) [Internet; cited 2025 June]. Available from: [7] A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) [Internet; cited 2025 June]. Available from: [8] A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer (INAVO123) [Internet; cited 2025 June]. Available from: Anderson E, et al. A Systematic Review of the Prevalence and Diagnostic Workup of PIK3CA Mutations in HR+/HER2– Metastatic Breast Cancer. Int J Breast Cancer. 2020;2020:3759179.[10] Juric D, et al. A phase I/Ib study of inavolisib (GDC-0077) in combination with fulvestrant in patients (pts) with PIK3CA-mutated hormone receptor-positive/HER2-negative (HR+/HER2–) metastatic breast cancer. Presented at San Antonio Breast Cancer Symposium, 2020 December 7-10; San Antonio, USA. Abstract #P5-17-05.[11] Hong R, et al. GDC-0077 is a selective PI3K alpha inhibitor that demonstrates robust efficacy in PIK3CA mutant breast cancer models as a single agent and in combination with standard of care therapies. Cancer Res. 2018;78(4):4-14.[12] A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, Her2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) [Internet; cited 2025 June]. Available from: National Cancer Institute: Surveillance, Epidemiology and Ends Result Program. Cancer Stat Facts: Female Breast Cancer Subtypes [Internet; cited 2025 June]. Available from: Lim E, et al. The natural history of hormone receptor-positive breast cancer. Oncology (Williston Park). 2012;26(8):688-94,696.[15] Wu VS, et al. From bench to bedside: What do we know about hormone receptor-positive and human epidermal growth factor receptor 2-positive breast cancer? J Steroid Biochem Mol Biol. 2015 Sep;153:45-53.[16] Tomas R and Barrios CH. Optimal management of hormone receptor positive metastatic breast cancer in 2016. Ther Adv Med Oncol. 2015;7(6):304-20.[17] Galipeau N, et al. Understanding key symptoms, side effects, and impacts of HR+/HER- advanced breast cancer: qualitative study findings. J Patient-Rep Outcomes. 2019;3(1): Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release EC approves Itovebi English
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Initiate the movement by passing the weight around your body, from front to back, in a circular motion. Keep the movement fluid and controlled, maintaining a stable core front raises. Do: 12 reps x 3 Stand with your feet hip-width apart, holding a dumbbell in each hand with palms facing your body. Keep your arms straight (with a slight bend in the elbows) and lift one arm forward and up to shoulder height, while keeping the other arm at your side. Lower the raised arm with control and repeat on the opposite side. That's one rep; alternate sides for the total number of raises. Do: 10 reps x 3 Stand with a dumbbell in each hand, arms by your sides, palms facing inwards. Ensure your shoulders are relaxed (not raised), your abs are engaged (think tensing, as opposed to breathing in), and there's a slight bend in your knees. Retaining this posture, lift the dumbbells out to the sides with straight arms, going no higher than shoulder height. Gradually (i.e. don't just let your arms fall back down, move with control) lower the dumbbells to the starting shoulder press. Do: 12 reps x 3 Stand with feet shoulder-width apart, holding a dumbbell in each hand at shoulder height with palms facing each other. A Alternately press one dumbbell overhead, extending the arm fully, while keeping the other dumbbell at shoulder height. Lower the raised arm back to the starting position and repeat on the other side, continuing to flies. Do 10 reps x3 Stand with your feet at a hip-width distance with a soft bend in your knees. With a neutral spine, hinge at the waist so your chest is lowered to near parallel with the floor and your hips come slightly backwards. With your arms straight down towards the floor, hold the dumbbells comfortably in your hands with a neutral grip (palms facing in towards each other). Have a soft bend in your elbows as you raise the weights up and out to the sides, in line with your shoulders; at this point, your palms should be facing down to the floor. Squeeze your upper back and in between your shoulder blades to assist the movement. Control the movement as you lower the weights back to the starting kickbacks. Do: 12 reps x 3 Stand with your knees bent and lean forward slightly, with a dumbbell in each hand. Keeping your back straight, bend your dumbell-holding arm 90 degrees at the elbow so your triceps are aligned with your back and your biceps are perpendicular to the floor. Engage your core and your triceps and hinge at the elbow, lifting the dumbbell up and back as you try and straighten your arm. Your triceps should stay still; only your elbow moves. Guide the weight upward until your arm is straight, pause, then lower back to 90 degrees. That's one curls. Do 10 reps x 3 Stand with your feet hip-width apart, holding weights in front of you, palms facing forward. Without moving your upper arms, slowly curl the weights toward your shoulders. At the top of the curl, rotate your wrists inward so your palms face forward. Slowly lower them in that position. Rotate your wrists and dumbbells back to the starting position. That's one Arnold press. Do: 8 each side x 3 Take a dumbbell in each hand. Stand with a shoulder-width stance and brace your core. Raise the dumbbells so they're shoulder height with your palms facing your body. Pull your shoulder blades back and down, then extend your arms up while rotating your wrists to the front, so that you end up with the dumbbells above your head with palms facing forward. Remaining stable, slowly lower the dumbbells and rotate the wrists so that the palms are facing towards you chest press. Do: 8 reps x 3 Stand with feet shoulder-width apart, holding a dumbbell in each hand at shoulder height, palms facing forward. Keeping your arms bent, bring your elbows and palms to touch while holding the dumbbells in the same position. Then open your arms back to the starting position, maintaining the same angle. That's one rep. Get the Workouts Get the Challenge Get the Workouts Get the Workouts Get the Challenge Get the Workouts Get the Challenge Get the Workouts Get the Workouts Get the Workouts Get the Workouts Get the Workouts Get the Workouts Get the Workouts Get the Challenge Get the Workouts You Might Also Like Jennifer Garner Swears By This Retinol Eye Cream These New Kicks Will Help You Smash Your Cross-Training Goals
