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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…
July 24, 2026

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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…
July 23, 2026

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Celcuity
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Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…
June 3, 2026

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Astrazeneca
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AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26

Shots: AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…
June 3, 2026

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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…
June 1, 2026

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Eli lilly
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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…
June 1, 2026

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NEWS

Cogent Biosciences Receives the US FDA Priority Review for Bezuclastinib Combination to Treat Gastrointestinal Stromal Tumors (GIST)

Shots: The US FDA has accepted NDA & granted priority review to Cogent's bezuclastinib + sunitinib for the treatment of pts with GIST who were treated with imatinib, with no advisory committee meeting planned yet (PDUFA: Nov 30, 2026) NDA was supported by the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx.…
May 29, 2026

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NEWS

OSE Immunotherapeutics Reports P-II (TEDOVA) Trial Data on Tedopi Combination in Recurrent Ovarian Cancer

Shots: OSE Immunotherapeutics has reported the topline P-II (TEDOVA/GINECO-OV244b/ENGOT-ov58) trial results evaluating Tedopi (OSE2101) ± Keytruda as a maintenance treatment in pts with Pt-sensitive recurrent ovarian cancer (PSOC)  Trial enrolled 185 pts with PSOC who progressed after or were ineligible for PARP inhibitors & Avastin. Pts achieving CR, PR, or stable disease after Pt-based therapy…
May 25, 2026

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