Highlights from the CHMP Jan 2026 Meeting are out! Indication Expansions 💊 Johnson & Johnson Innovative Medicine's niraparib & abiraterone acetate co-formulation (Akeega; PARP x CYP17 inhibitor) is indicated with prednisone or prednisolone in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) and BRCA 1/2 mutations (germline and/or somatic) 💊 Incyte and Takeda's ponatinib (Iclusig

April 4th Week, 2025 Regulatory & Market News 🎯 Akeso Biopharma’s penpulimab-kcqx (anti-PD-1) + chemo received the US FDA approval for the Tx of previously untreated recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (nkNPC). 👉 The FDA also approved single agent penpulimab-kcqx for the Tx of nkNPC patients who have progressed following platinum chemo and at least one other prior line of therapy. (Ref 1) ❓ How does this approval affect the current Tx landscape

April 3rd Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’s nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the US FDA as a first-line Tx of unresectable/metastatic hepatocellular carcinoma. (Ref 1) ❓ What portion of the first-line HCC patients are anticipated to transition to the nivolumab + ipilimumab regimen? 🎯 ImmunityBio, Inc. completed the sBLA submission to the US FDA for nogapendekin alfa inbakicept (IL-15 superagonist fusion protein) + B

March 1st Week, 2025 Regulatory Events 🎯 Bristol Myers Squibb’ nivolumab (anti-PD-1) + ipilimumab (anti-CTLA-4) has been approved by the EC as a first-line Tx for unresectable or advanced HCC. (Ref 1) ❓ How do the outcomes of nivolumab + ipilimumab compare against the previously approved Tx options for the first-line HCC? 🎯 Johnson & Johnson's amivantamab (EGFR x MET BsAb) + lazertinib (EGFR TKI) has been approved by the UK's MHRA for EGFR mutant, metastatic NSCLC. (Ref 2)

February 4th Week, 2025 📝 Merck & Co/ MSD's sBLA for neoadjuvant pembro followed by adjuvant pembro + RT ± cisplatin in resectable, LA SCCHN has been accepted by the US FDA for priority review (PDUFA date: Jun 23, 2025) (Ref 1) ❓ It is set to be the first approved Tx option for perioperative LA SCCHN. What are its challengers in the pipeline? 📝 BMS’ sBLA for nivo + ipi as a 1L Tx for adult and pediatric patients with unresectable or metastatic, MSI-H/dMMR colorectal canc

February 3rd Week, 2025 📝With the Ph3 CHECKMATE-816 trial meeting its key secondary endpoint of OS, BMS’ nivo + platinum-doublet CT became the first neoadjuvant-only Tx to significantly improve OS in resectable NSCLC patients. (Ref 1) ❓Will the positive OS data support BMS’ regimen in tackling the competitive threat from the perioperative chemo-IO regimens? 📝The US FDA will be assessing BI's NDA of zongertinib (irreversible ERBB2 TKI) for previously treated, HER2+ve, unres

Highlights from the CHMP March 2025 Meeting are out! ⭐ Indication Expansions: 💊 Pfizer's bosutinib (Bosulif; second-generation BCR-ABL TKI) use is extended to children aged 6 years and older with certain types of chronic myelogenous leukaemia, along with a new pharmaceutical form (hard capsules), associated with two new strengths (50 mg and 100 mg). 💊 AstraZeneca's acalabrutinib (Calquence; BTK inhibitor) + rituximab (anti-CD20 mAb) + bendamustine for the Tx of adult pati

Highlights from the Committee for Medicinal Products for Human Use (CHMP) January 2025 Meeting are out! Here are the positive recommendations in the Oncology space (Ref 1): ⭐ New Therapies: 👉 AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (TROP2-directed ADC) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer (post-endocrine therapy + chemo) 👉 Pfizer, Zai Lab, and Genmab's tisotumab vedotin (tissue factor-di