Ibrutinib

Ibrutinib/Nivolumab Combination Shows Promising 77.8% Response Rate in Relapsed CNS Lymphoma Trial

8 days ago

• A phase 2 trial of ibrutinib plus nivolumab demonstrated a high objective response rate of 77.8% in patients with relapsed/refractory central nervous system lymphoma, with 50% achieving complete responses. • At a median follow-up of 31 months, the median overall survival was 21 months, with 17% of patients experiencing durable remissions lasting more than two years without additional treatment. • The combination therapy was well-tolerated with manageable side effects, though 50% of patients experienced at least one grade 3-4 treatment-related adverse event, most commonly neutropenia and oral mucositis.

Royalty Pharma Secures 99.9% Shareholder Approval for $1.1 Billion External Manager Acquisition

9 days ago

• Royalty Pharma shareholders have overwhelmingly approved the acquisition of its external manager, with 99.9% voting in favor at the company's 2025 Annual General Meeting. • The $1.1 billion transaction will transition Royalty Pharma from an external management model to an integrated corporate structure, generating projected cash savings exceeding $1.6 billion over ten years. • The internalization is expected to strengthen corporate governance, enhance transparency, and better align leadership with shareholder interests while ensuring management continuity.

AbbVie Enters Indian Oncology Market with Venetoclax for Blood Cancer Treatment

a month ago

• AbbVie has launched Venetoclax in India for the treatment of Acute Myeloid Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL), marking its entry into the Indian oncology market. • Venetoclax, a first-in-class BCL-2 inhibitor, offers a novel oral treatment option for patients unable to undergo intensive chemotherapy due to age or other health conditions. • Priced at Rs 15,900 per bottle (approximately Rs 30,000 monthly), AbbVie will implement a patient access program to provide financial support while expanding distribution to tier-2 and tier-3 cities.

Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu

a month ago

• Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care. • Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations. • Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.

Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate

a month ago

• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests. • The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods. • The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.

2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars

a month ago

• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition. • Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition. • The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.

AbbVie Diversifies Portfolio with FDA Priority Review for Upadacitinib as Humira Faces Biosimilar Competition

3 months ago

• AbbVie's JAK1-selective inhibitor upadacitinib has received FDA Priority Review for moderate to severe rheumatoid arthritis, with potential annual sales projected to reach $3 billion. • The company is strategically expanding its portfolio as its blockbuster Humira faces biosimilar competition in Europe, with international sales already declining 15% despite continued growth in the US market. • Beyond upadacitinib, AbbVie's diversification strategy includes promising candidates like risankizumab for psoriasis and established cancer drugs Imbruvica and Venclexta, alongside recently approved Orilissa for endometriosis.

Bipartisan EPIC Act Seeks to Eliminate IRA's Small Molecule Drug Development Disincentive

3 months ago

• House legislators have reintroduced the bipartisan EPIC Act aimed at equalizing negotiation timelines between small molecule drugs and biologics under the Inflation Reduction Act. • The current IRA framework creates a 'pill penalty' by allowing only 9 years before price negotiations for small molecules compared to 13 years for biologics, potentially reducing revenue by 50% during critical years. • Industry experts argue the legislation is crucial for maintaining investment in small molecule drug development and ensuring patient access to future life-saving medicines.

Brukinsa Demonstrates Superior Safety Profile Compared to Imbruvica in CLL Treatment Study

3 months ago

• A new study comparing BTK inhibitors in chronic lymphocytic leukemia treatment shows Brukinsa (zanubrutinib) had fewer severe side effects than Imbruvica (ibrutinib), with 4% versus 9% incidence respectively. • Notable findings include complete absence of neutropenia in the Brukinsa group compared to 3% in the Imbruvica group, suggesting particular benefits for older or immunocompromised patients. • Treatment discontinuation and dose reductions were less frequent with Brukinsa, though researchers emphasize the importance of personalized treatment decisions based on individual patient characteristics.

Tambiciclib-Zanubrutinib Combo Shows 67% Response Rate in Relapsed/Refractory DLBCL Trial

3 months ago

• Phase 2a trial demonstrates promising 67% overall response rate for tambiciclib plus zanubrutinib combination in relapsed/refractory DLBCL patients, including one complete response. • The combination therapy showed particularly strong efficacy in ABC DLBCL subtype patients, achieving an 83% disease control rate with 4 responses and 1 stable disease out of 6 patients. • Safety profile reveals grade 3 or higher adverse effects in 55.6% of patients, while genetic analysis indicates efficacy independent of MYD88 or CD79B mutations.

Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma

4 months ago

• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant. • The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone. • Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement. • Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.

AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC

5 months ago

• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial. • The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients. • A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients. • Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.

Kymriah Receives EU Approval as First CAR-T Therapy for Follicular Lymphoma

5 months ago

• Novartis' Kymriah is the first CAR-T therapy approved in the EU for relapsed/refractory follicular lymphoma, offering a new option for patients after multiple treatments. • The approval was based on the ELARA trial, demonstrating an 86% response rate and 69% complete response rate in patients treated with Kymriah. • Kymriah provides durable treatment effects, with 87% of complete responders remaining in remission for at least nine months after initial response. • This approval expands Kymriah's indications in the EU, adding to its existing approvals for diffuse large B-cell lymphoma and acute lymphoblastic leukemia.

Acalabrutinib Plus Venetoclax Significantly Improves PFS in Untreated CLL

5 months ago

• The phase 3 AMPLIFY trial demonstrated that acalabrutinib plus venetoclax, with or without obinutuzumab, significantly improved progression-free survival (PFS) in treatment-naive CLL patients. • The doublet and triplet regimens reduced the risk of disease progression or death by 35% and 58%, respectively, compared to chemoimmunotherapy. • The highest rates of undetectable minimal residual disease (uMRD) were observed in patients treated with the triplet regimen of acalabrutinib, venetoclax, and obinutuzumab. • The combination provides a chemotherapy-free, fixed-duration option for previously untreated CLL, offering improved outcomes and flexibility in managing the disease.

Eli Lilly's Zepbound Demonstrates Superior Weight Loss Compared to Novo Nordisk's Wegovy in Head-to-Head Trial

6 months ago

• Eli Lilly's Zepbound (tirzepatide) led to a 20.2% average weight loss, significantly outperforming Wegovy (semaglutide) at 13.7% in a 72-week clinical trial. • The SURMOUNT-5 trial included overweight or obese adults without diabetes, showing Zepbound users experienced 47% more relative weight loss than Wegovy users. • Zepbound, a dual GIP and GLP-1 receptor agonist, helped 31.6% of participants achieve at least 25% body weight loss, compared to 16.1% with Wegovy. • The study's findings may influence treatment choices, with Zepbound potentially becoming a preferred option for greater weight loss outcomes, pending further data on tolerability.

Evolving Landscape of Oncology Clinical Trials: Expert Insights on Precision Medicine and Patient Recruitment

11 years ago

• The rise of targeted therapies in oncology has created new challenges in patient recruitment, with some trials requiring screening of large populations to find participants with specific genetic mutations. • Administrative burdens and limited investigator pools continue to impact trial timelines, with some academic centers taking up to nine months for trial initiation. • Recent advances in chronic lymphocytic leukemia treatment, including breakthrough therapies like Imbruvica and Idelalisib, demonstrate both progress and challenges in conducting subsequent trials.

Drug Development Updates