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Asset / Drug

palbociclib

Drug and asset intelligence for palbociclib with 10 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
6
Catalysts
4
Stage
Development stage unavailable

Sponsor company

Dr. Reddy's Laboratories →

Mechanism of action

6 Inhibitor

Recent signals(6)

StrategyAugust 9, 2026

FDA Submission Update for Palbociclib by Dr. Reddy's Laboratories

Reddy's Laboratories has submitted an original application (ANDA220444) for palbociclib, currently under standard review.

ClinicalAugust 4, 2026

Study on Palbociclib Combinations in HR+HER2-MBC Initiated in Africa and Middle East

A non-interventional study is underway to gather data on treatment patterns and outcomes for palbociclib in HR+ HER2-positive metastatic breast cancer.

Strategy
July 19, 2026

FDA Submission for Palbociclib by Dr. Reddy's Laboratories

Reddy's Laboratories has submitted an original Abbreviated New Drug Application (ANDA) for Palbociclib.

RegulatoryJuly 15, 2026

FDA approves gedatolisib with fulvestrant for HR-positive, HER2-negative breast cancer

The FDA has approved gedatolisib in combination with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative breast cancer.

ClinicalJuly 13, 2026

Phase II Trial of Palbociclib in Cancers with CCND Amplifications Shows Potential Targeted Treatment

The MATCH-Subprotocol Z1B trial is evaluating palbociclib's efficacy in cancers with CCND1, 2, or 3 amplifications.

RegulatoryJune 25, 2026

FDA Approves Palbociclib with Trastuzumab for HR-positive, HER2-positive Breast Cancer

The FDA has approved palbociclib in combination with trastuzumab, with or without pertuzumab, for maintenance treatment in HR-positive, HER2-positive metastatic breast cancer.

Upcoming milestones

No catalysts indexed for this entity yet.

Related catalysts(4)

Topline Data

Dr. Reddy's Laboratories — Palbociclib

July 19, 2026 · N/A

Topline Data

— palbociclib

July 15, 2026 · N/A

Topline Data

— Palbociclib

July 13, 2026 · N/A

Topline Data

Pfizer — palbociclib

June 25, 2026 · N/A

Indications

Breast Cancer →

Therapeutic areas

6 Inhibitor →
Breast Cancer →
CDK4 →
Oncology →
Oncology · Breast Cancer →

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