Medicosnext
Yet again there has been a clash between global pharmaceutical giant Roche and Indian drug maker Zydus Lifesciences. Roche has filed a complaint against Zydus regarding alleged critical gaps in the clinical trials of its biologic drug Perjeta, a widely-used breast cancer treatment. This isn’t the first time these two companies have found themselves in a legal battle; a similar dispute arose in 2016 over the approval and launch of breast cancer drug Vivitra by Zydus Cadila.
Roche’s primary contention revolves around the procurement of the drug used in the initial phase of clinical trials by Zydus. The Swiss biotech company claims that the drug was not obtained directly from them, raising concerns about its quality and authenticity. Roche suggests the possibility that the drug used by Zydus might be of “questionable quality,” “compromised,” or even “spurious.”
Zydus, based in Ahmedabad, vehemently denies these allegations, viewing them as an attempt to tarnish its reputation and undermine its efforts to make expensive drugs accessible at affordable prices in the Indian market. The company’s spokesperson clarified that Zydus had procured 480 vials of the original innovator reference product (Perjeta) directly from Roche Pharma India in January 2023, and the trial vials in 2022 were not purchased from Roche. The clinical trial, according to the Clinical Trials Registry of India (CTRI), commenced in September 2022.
This clash between Roche and Zydus adds another chapter to their history of legal disputes, recalling the 2016 lawsuit over the approval and launch of a biosimilar version of Roche’s trastuzumab, known as Vivitra, by Zydus Cadila. The pharmaceutical industry will closely watch how this latest dispute unfolds and its potential impact on the breast cancer treatment landscape.
Rusfertide for Polycythemia Vera
Polycythemia vera, a chronic myeloproliferative neoplasm, is known for its challenging management due to erythrocytosis. In a groundbreaking development, a new injectable peptide mimetic, Rusfertide, has shown remarkable efficacy in controlling erythrocytosis and reducing the need for phlebotomy in patients with polycythemia vera. The REVIVE trial, led by an esteemed team of researchers including Marina Kremyanskaya, M.D., Ph.D., and Srdan Verstovsek, M.D., Ph.D., provides crucial insights into the safety and effectiveness of Rusfertide.
The trial, conducted in the United States and India, comprised two main phases. Part 1 involved a 28-week open-label assessment to determine the optimal dosage of Rusfertide. During this period, the mean number of phlebotomies significantly decreased from 8.7±2.9 to 0.6±1.0 per year, demonstrating the drug’s effectiveness. Part 2, a double-blind randomized withdrawal period, showed that 60% of patients receiving Rusfertide achieved a response, defined by hematocrit control, absence of phlebotomy, and trial completion, compared to 17% in the placebo group.
Rusfertide’s mechanism of action involves acting as a hepcidin mimetic, regulating iron availability for erythropoiesis. It proved successful in maintaining hematocrit levels below 45%. Importantly, patient-reported outcomes indicated a reduction in disease-related symptoms, showcasing the drug’s potential to improve quality of life.
While Rusfertide demonstrated a favorable safety profile, including manageable injection-site reactions and a low incidence of adverse events, the study acknowledges the need for further trials to assess long-term effects and complications.
This groundbreaking research heralds Rusfertide as a promising therapeutic option for polycythemia vera, potentially transforming the landscape of its management. Ongoing phase 3 trials will provide a deeper understanding of Rusfertide’s long-term impact, offering hope for improved outcomes and quality of life for patients with this challenging condition.
Reference: https://www.nejm.org/doi/full/10.1056/NEJMoa2308809
Osimertinib Plus Chemotherapy for Advanced EGFR-Mutated Lung Cancer
The recent FDA approval of a groundbreaking therapy with Osimertinib has transformed the landscape of non-small cell lung cancer (NSCLC) treatment. Osimertinib, known by its brand name Tagrisso, in combination with chemotherapy, has received the regulatory nod for the treatment of locally advanced or metastatic Epidermal Growth Factor Receptor EGFR-mutated NSCLC. This milestone decision is anchored in the compelling results of the phase 3 FLAURA2 trial (NCT04035486).
Osimertinib belongs to a class of drugs known as tyrosine kinase inhibitors, which work by blocking signals that promote the growth of cancer cells. Initially approved as a monotherapy for locally advanced or metastatic EGFR-mutated NSCLC, its recent FDA approval in combination with chemotherapy represents a milestone. The FLAURA2 trial has demonstrated a 38% reduction in the risk of disease progression or death when Osimertinib was combined with chemotherapy. The impressive improvement in progression-free survival was emphasized by Dr. Joshua Sabari, a key investigator, who highlighted the median PFS extension by 8.8 months compared to osimertinib monotherapy. This advantage was consistently observed across patient subgroups, including those with central nervous system metastases.
The FDA’s approval extends the usage of osimertinib, which was already approved as a monotherapy for various NSCLC indications. The breakthrough therapy designation granted in August 2023 underscores the therapeutic potential of osimertinib plus chemotherapy in this patient population. The manageable safety profile of the combination, despite a higher incidence of grade 3 or higher adverse events is noteworthy. Importantly, the responses in the combination arm surpassed those in the monotherapy arm, with a higher percentage of complete or partial responses and an extended median response duration. The FLAURA2 trial marks a significant step forward in the pursuit of improved treatment options for EGFR-mutated NSCLC, providing hope for enhanced outcomes and better quality of life for patients facing this challenging diagnosis. This approval signals a promising future for the integration of targeted therapies and chemotherapy in the evolving landscape of lung cancer treatment.
Reference: https://www.targetedonc.com/view/fda-oks-osimertinib-plus-chemo-in-egfr-mutant-lung-cancer
