AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US Approval was based on the P-III (SERENA-6) trial assessing…

ByRidhi RastogiJuly 24, 2026

NEWS

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Shots: The US FDA has accepted sNDA & granted priority review to Talzenna (talazoparib) + Xtandi (enzalutamide) to treat men with HRR gene-altered mCSPC, with PDUFA action date in Q4’26. Regulatory review is ongoing in the EU sNDA was supported by the P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi…

ByRidhi RastogiJuly 24, 2026

NEWS

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Shots: The US FDA has accepted the NDA for Revolution Medicines’ daraxonrasib to treat pts with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), plus daraxonrasib was selected for the FDA CNPV pilot program NDA was backed by P-III (RASolute 302) trial assessing daraxonrasib (300mg, QD, PO) vs CT, in above-mentioned pts, regardless of RAS mutation, which…

ByRidhi RastogiJuly 23, 2026

NEWS

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Shots: The US FDA has granted Priority Review to the sBLA of Gazyva/Gazyvaro (obinutuzumab) in pMN, based on the P-III (MAJESTY) study assessing Gazyva vs tacrolimus in adults (n=142), with a decision expected by Nov 2026 Trial met its 1EP, with 36.9% adults achieving CR at 2yrs. vs 5.7%, plus showed superiority across key 2EPs…

ByRidhi RastogiJuly 15, 2026

NEWS

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Shots: The US FDA has approved Tryngolza (olezarsen; 50 or 80mg, QM) as an adjunct to diet to reduce triglycerides (TG) & the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG); commercially available in Jul 2026 Approval was based on the P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (SC) vs PBO…

ByRidhi RastogiJune 26, 2026

NEWS

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Shots: The US FDA has approved Pfizer's Ibrance (palbociclib) + trastuzumab ± pertuzumab, & endocrine therapy for the maintenance treatment of adults with HR+, HER2+ locally advanced or metastatic breast cancer following induction treatment Approval was based on the AFT-sponsored P-III (PATINA) trial, where pts receiving a median of 6 cycles of induction treatment were…

ByRidhi RastogiJune 25, 2026

NEWS

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Shots: The US FDA has accepted sBLA & granted priority review to adj. Tecentriq (atezolizumab) & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) in combination with CT in stage III dMMR or MSI-H colon cancer (PDUFA: Oct 9, 2026) sBLA was based on the P-III (ATOMIC) trial assessing Tecentriq to FOLFOX6 CT in 712 pts with stage…

ByRidhi RastogiJune 11, 2026

NEWS

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

Shots: The EC has approved Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) who require systemic therapy following disease progression on or after 1L treatment with Pt-based CT Approval was based on the P-III (DeLLphi-304) trial assessing Imdelltra vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the…

ByRidhi RastogiJune 2, 2026

NEWS

Revolution Medicines Highlights P-III (RASolute 302) Trial Results on Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

Shots: As of Feb 10, 2026 (mFU: 8.5mos.), the P-III trial assessing daraxonrasib (300mg, QD, PO; n=248) vs CT (n=252) in previously treated metastatic PDAC, regardless of RAS mutation, met all 1 & key 2EPs, showing benefits in both the RAS G12 mutant (daraxonrasib n=228; CT n=231) & overall population Daraxonrasib improved OS by 60% in…

ByRidhi RastogiJune 1, 2026

NEWS

Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026

Shots: Lilly's global P-III (LIBRETTO-432) trial assessed Retevmo (selpercatinib; 160mg, BID) vs PBO in 151 pts with early-stage (IB-IIIA) RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy Trial met the 1EP, improving the EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of…

ByRidhi RastogiJune 1, 2026

AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Pfizer Receives the US FDA Priority Review for Talzenna + Xtandi to Treat HRR-Gene Mutated mCSPC

Revolution Medicines Reports the US FDA NDA Acceptance of Daraxonrasib for Previously Treated Metastatic PDAC

Roche Receives the US FDA Priority Review for Gazyva to Treat Primary Membranous Nephropathy

Ionis’ Tryngolza Receives the US FDA Approval for Patients with Severe Hypertriglyceridemia

Pfizer’s Ibrance Combination Receives FDA Approval as a Maintenance Therapy for HR+, HER2+ Metastatic Breast Cancer

Genentech’s Tecentriq Receives the US FDA Priority Review for Stage III dMMR/MSI-H Colon Cancer

Amgen Reports the EC Approval of Imdylltra to Treat ES-SCLC

Revolution Medicines Highlights P-III (RASolute 302) Trial Results on Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

Eli Lilly Highlights P-III (LIBRETTO-432) Trial Data on Retevmo for Early-Stage RET Fusion–Positive NSCLC at ASCO 2026

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